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Italy initiated elexacaftor/tezacaftor/ivacaftor (ETI) for people with cystic fibrosis (pwCF) in July 2021. It has led to dramatic improvements in lung function, BMI, sweat chloride, and respiratory symptoms. However, few data are available on side effects or effects on a broad range of outcomes. How does ETI affect mental health, cognitive processing, neuropsychological side effects, GI symptoms, and health-related quality of life over time? This was a prospective, "real-world" longitudinal study. Participants were recruited consecutively and evaluated at initiation (T0) and after 1 month, 3 months, and 6 months of starting treatment. Assessments included depression (nine-item Patient Health Questionnaire), anxiety (seven-item Generalized Anxiety Disorder), cognition (Symbol Digit Modalities Test), GI Symptom Tracker, and health-related quality of life (Cystic Fibrosis Questionnaire-Revised). Based on literature, an ad hoc questionnaire was developed to assess side effects: insomnia, headache, memory problems, "brain fog," and concentration problems. Following descriptive analyses, longitudinal data were analyzed by using mixed models for repeated measures, controlling for age and sex when appropriate. Ninety-two consecutive pwCF (female/male, 46/46; mean age, 25.4 years) participated. FEV 1 increased initially and then remained stable. BMI also increased significantly from T0 to 6 months (P <.01). Depression improved from T0 to 1 month (P <.001); however, no changes in anxiety were found. Cognitive processing improved from T0 to subsequent assessments. Positive changes were reported on the GI Symptom Tracker for stools and adherence challenges, although no changes were found for abdominal pain and digestion. Side effects occurred in 10% to 29%, with no reduction over time; insomnia increased significantly across time. Female participants reported more side effects than male participants (ie, insomnia, headache, concentration problems, brain fog). This prospective study evaluated the effects of ETI using multiple measures. Significant improvements were found in many domains; however, side effects were reported by a substantial proportion of pwCF, with no improvements over time. Female participants reported more side effects than male participants. pwCF should be followed up systematically to assess the frequency of side effects after starting this new modulator. [ABSTRACT FROM AUTHOR]

Abstract Background Women experience more severe gastrointestinal (GI) symptoms compared to men. The onset of puberty and the menstrual cycle may influence these differences. Additionally, health anxiety is an important construct that has been shown to play a role in increased symptomatology across many medical conditions. Using standardized clinical measures often employed to assess disorders of gut-brain interaction (DGBI) we aimed to identify differences of GI functioning across menstrual cycle phases and to evaluate the role of health anxiety in this relationship. Methods Six hundred three participants completed a survey including functional GI assessment scales (PROMIS-GI®), an abdominal pain scale and map, and a health anxiety measure. They were grouped by menstrual cycle phases (Menses, Follicular, Early-Luteal, and Premenstrual) based on self-reported start date of most recent period. Multivariate analyses of covariance were conducted to identify differences between menstrual cycle phase and scores on the symptom scales. Heath anxiety was included as a covariate in all analyses. Results No significant differences were found between menstrual cycle group and PROMIS-GI scores. Higher GI-symptom and pain levels were found as health anxiety increased. Pain in the hypogastric region of the abdomen was significantly higher during the Menses phase when compared to Early-Luteal and Premenstrual phases. A subset of participants with DGBI diagnoses demonstrated significantly higher GI-symptom severity on several PROMIS-GI scales when compared to matched controls who did not have those diagnoses. In addition, participants with DGBI diagnoses reported significantly greater pain across multiple abdominal regions than their non-diagnosed counterparts. Conclusions GI symptom levels as measured by the PROMIS-GI scales in otherwise healthy women were not dependent on menstrual cycle phase. Yet, the PROMIS-GI scales were sensitive to symptom differences in women with DGBI diagnoses. Overall, this study demonstrated that the PROMIS-GI measures are unlikely to be affected by gynecological functioning in healthy young women. We argue that the abdominal pain map is an essential addition to classification and diagnosis.

Background: Women experience more severe gastrointestinal (GI) symptoms compared to men. The onset of puberty and the menstrual cycle may influence these differences. Additionally, health anxiety is an important construct that has been shown to play a role in increased symptomatology across many medical conditions. Using standardized clinical measures often employed to assess disorders of gut-brain interaction (DGBI) we aimed to identify differences of GI functioning across menstrual cycle phases and to evaluate the role of health anxiety in this relationship. Methods: Six hundred three participants completed a survey including functional GI assessment scales (PROMIS-GI®), an abdominal pain scale and map, and a health anxiety measure. They were grouped by menstrual cycle phases (Menses, Follicular, Early-Luteal, and Premenstrual) based on self-reported start date of most recent period. Multivariate analyses of covariance were conducted to identify differences between menstrual cycle phase and scores on the symptom scales. Heath anxiety was included as a covariate in all analyses. Results: No significant differences were found between menstrual cycle group and PROMIS-GI scores. Higher GI-symptom and pain levels were found as health anxiety increased. Pain in the hypogastric region of the abdomen was significantly higher during the Menses phase when compared to Early-Luteal and Premenstrual phases. A subset of participants with DGBI diagnoses demonstrated significantly higher GI-symptom severity on several PROMIS-GI scales when compared to matched controls who did not have those diagnoses. In addition, participants with DGBI diagnoses reported significantly greater pain across multiple abdominal regions than their non-diagnosed counterparts. Conclusions: GI symptom levels as measured by the PROMIS-GI scales in otherwise healthy women were not dependent on menstrual cycle phase. Yet, the PROMIS-GI scales were sensitive to symptom differences in women with DGBI diagnoses. Overall, this study demonstrated that the PROMIS-GI measures are unlikely to be affected by gynecological functioning in healthy young women. We argue that the abdominal pain map is an essential addition to classification and diagnosis. [ABSTRACT FROM AUTHOR]

Gastrointestinal (GI) symptoms are frequently reported in children with autism spectrum disorder (ASD). We evaluated the frequency and severity of GI symptoms in preschool-aged children with ASD compared to participants with typical development (TD). Our goal was to ascertain whether GI symptoms are associated with differences in sex or developmental and behavioral measures. Participants were between 2 and 3.5 years of age and included 255 children with ASD (184 males/71 females) and 129 age-matched TD controls (75 males/54 females). A parent interview was used to assess GI symptoms (abdominal pain, gaseousness/bloating, diarrhea, constipation, pain on stooling, vomiting, difficulty swallowing, blood in stool or in vomit). Children with GI symptoms in each diagnostic group were compared to children without GI symptoms on measures of developmental, behavioral, and adaptive functioning. GI symptoms were reported more frequently in children with ASD compared to the TD group (47.8% vs. 17.8%, respectively). Children with ASD were also more likely to experience multiple GI symptoms (30.6% vs. 5.4%). GI symptoms were equally common in males and females across both diagnostic groups. There were no statistically significant differences in developmental or adaptive measures based on presence of GI symptoms in either ASD or TD children. Co-occurring GI symptoms were, however, associated with increased self-injurious behaviors, restricted stereotyped behaviors, aggressive behaviors, sleep problems and attention problems in both ASD and TD children. In children with ASD, a higher number of GI symptoms was associated with an increase in self-injurious behaviors, somatic complaints, reduced sleep duration, and increased parasomnias. LAY SUMMARY: ASD is characterized by challenges in social communication and repetitive behaviors. But, people with autism have many other difficulties including gastrointestinal problems. Children with ASD were three times more likely to experience GI symptoms than typically developing peers. Increased GI symptoms are associated with increased problem behaviors such as sleep problems, self-injury, and body aches. Since GI symptoms are often treatable, it is important to recognize them as soon as possible. Both clinicians and parents should become more aware of the high occurrence of GI problems in autistic people. Autism Res 2020, 13: 1778-1789. © 2020 International Society for Autism Research and Wiley Periodicals LLC.

BACKGROUND: Acne is a common skin disorder among younger age group. Dietary pattern are the key determinants among acne patients. The objective of this study is to determine the association of acne vulgaris with dietary habits among patients at tertiary care hospital in Karachi, Pakistan. METHODS: it is a cross sectional study and participants were selected through simple random sampling from outpatient department of tertiary care hospital in Karachi, Pakistan. Patients presenting with acne irrespective of severity and treatment were included in the study. Bivariate analyses conducted at 95% CI and p=<0.05 considered statistically significant. RESULTS: Females gender (62%) and family history (61%) was significantly associated with acne. Face region was most (92%) affected by acne. GI upset most common co-morbid illness with Acne (p=0.006). After adjustment of covariate, those consume oily food [Daily oily food; Twice a weekly oily food)]; sugar rich food [Daily consumed sugar; Twice a weekly consumed] and less glass of water [8-10 glass per day; 6-8 glass per day; less than 6 glass per] were significantly associated with acne. CONCLUSION: Study found that un-healthy diet is significantly associated with acne. Common dietary predictors for acne were frequent use of oily food, sugary food, and less amount of drink water. [ABSTRACT FROM AUTHOR]

Abstract Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) can cause gastrointestinal (GI) symptoms that often correlate with the severity of COVID‐19. Here, we explored the pathogenesis underlying the intestinal inflammation in COVID‐19. Plasma VEGF level was particularly elevated in patients with GI symptoms and significantly correlated with intestinal edema and disease progression. Through an animal model mimicking intestinal inflammation upon stimulation with SARS‐CoV‐2 spike protein, we further revealed that VEGF was over‐produced in the duodenum prior to its ascent in the circulation. Mechanistically, SARS‐CoV‐2 spike promoted VEGF production through activating the Ras‐Raf‐MEK‐ERK signaling in enterocytes, but not in endothelium, and inducing permeability and inflammation. Blockage of the ERK/VEGF axis was able to rescue vascular permeability and alleviate intestinal inflammation in vivo. These findings provide a mechanistic explanation and therapeutic targets for the GI symptoms of COVID‐19.

• No difference in alpha-diversity but increased beta-diversity in ASD people. • Altered gut microbiotas associated with autistic and other behavioral symptoms. • No association between GI symptoms and altered taxonomic diversity in ASD. • A complex relationship between altered microbiome, immune dysregulation, and ASD. Despite inconsistent results across studies, emerging evidence suggests that the microbial micro-environment may be associated with autism spectrum disorder (ASD). Geographical and cultural factors highly impact microbial profiles, and there is a shortage of data from East Asian populations. This study aimed to comprehensively characterize microbial profiles in an East Asian sample and explore whether gut microbiota contributes to clinical symptoms, emotional/behavioral problems, and GI symptoms in ASD. We assessed 82 boys and young men with ASD and 31 typically developing controls (TDC), aged 6–25 years. We analyzed the stool sample of all participants with 16S V3-V4 rRNA sequencing and correlated its profile with GI symptoms, autistic symptoms, and emotional/behavioral problems. Autistic individuals, compared to TDC, had worse GI symptoms. There were no group differences in alpha diversity of species richness estimates (Shannon-wiener and Simpson diversity indices). Participants with ASD had an increased relative abundance of Fusobacterium , Ruminococcus torques group (at the genus level), and Bacteroides plebeius DSM 17135 (at the species level), while a decreased relative abundance of Ruminococcaceae UCG 013, Ervsipelotrichaceae UCG 003, Parasutterella, Clostridium sensu stricto 1, Turicibacter (at the genus level), and Clostridium spiroforme DSM 1552 and Intestinimonas butyriciproducens (at the species level). Altered taxonomic diversity in ASD significantly correlated with autistic symptoms, thought problems, delinquent behaviors, self dysregulation, and somatic complaints. We did not find an association between gut symptoms and gut microbial dysbiosis. Our findings suggest that altered microbiota are associated with behavioral phenotypes but not GI symptoms in ASD. The function of the identified microbial profiles mainly involves the immune pathway, supporting the hypothesis of a complex relationship between altered microbiome, immune dysregulation, and ASD that may advance the discovery of molecular biomarkers for ASD. [ABSTRACT FROM AUTHOR]

The novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has emerged and is responsible for the Coronavirus Disease 2019 global pandemic. Coronaviruses, including SARS-CoV-2, are strongly associated with respiratory symptoms during infection, but gastrointestinal symptoms, such as diarrhea, vomiting, nausea, and abdominal pain, have been identified in subsets of COVID-19 patients. This article focuses on gastrointestinal symptoms and pathophysiology in COVID-19 disease. Evidence suggests that the gastrointestinal tract could be a viral target for SARS-CoV-2 infection. Not only is the SARS-CoV-2 receptor ACE2 highly expressed in the GI tract and is associated with digestive symptoms, but bleeding and inflammation are observed in the intestine of COVID-19 patients. We further systemically summarize the correlation between COVID-19 disease, gastrointestinal symptoms and intestinal microbiota. The potential oral-fecal transmission of COVID-19 was supported by viral RNA and live virus detection in the feces of COVID-19 patients. Additionally, the viral balance in the GI tract could be disordered during SARS-CoV-2 infection which could further impact the homeostasis of the gut microbial flora. Finally, we discuss the clinical and ongoing trials of treatments/therapies, including antiviral drugs, plasma transfusion and immunoglobulins, and diet supplementations for COVID-19. By reviewing the pathogenesis of SARS-CoV-2 virus, and understanding the correlation among COVID-19, inflammation, intestinal microbiota, and lung microbiota, we provide perspective in prevention and control, as well as diagnosis and treatment of the COVID-19 disease.

Background/Aims Compared with other ethnic groups of midlife women, African American midlife women tend to experience more vasomotor symptoms during their menopausal transition. Furthermore, there are differences in the prevalent or severe symptoms between African American midlife women and other ethnic groups of midlife women. Despite these findings, little is still known on African American midlife women's menopausal symptom experience, especially their gastrointestinal (GI) symptoms. The purpose of this secondary analysis was to determine the characteristics linked to African American midlife women with high GI symptoms during the menopausal transition. Methods This secondary analysis used the data among 249 African American midlife women from two Internet surveys. In the original studies, midlife women's menopausal symptom experience (including GI symptoms) was explored among four racial/ethnic minority groups. The instruments included the Midlife Women's Symptom Index (based on the Cornell Medical Index) and various questions on sociodemographic and health characteristics. The data analysis was conducted using multiple logical regression and hierarchical multiple linear regression analyses. As a reference group, the data among 315 non-Hispanic White women were used. Results Compared to N-H Whites, N-H African Americans were more likely to report weight loss, weight gain, and heartburn (OR=2.07, 1.68, and 1.68 respectively). They were less likely to report diarrhea (OR=0.24) than N-H Whites. Those with very low family income (β=0.15), with a diagnosed GI disease (β=0.12), and/or with post-menopausal status (pre-menopausal, β=-0.76; peri-menopausal, β=-0.43) tended to report higher total numbers of GI symptoms. Those with low family income (β=0.19), with a diagnosed GI disease (β=0.13), and/or with post-menopausal status (pre-menopausal, β=-0.75; per-menopausal, β=-0.48) tended to report higher total severity scores of GI symptoms. Conclusion The characteristics linked to African American midlife women's GI symptoms could provide important information for future intervention development among this specific population.. [ABSTRACT FROM AUTHOR]

Background/Aims The prevalence of menopausal symptoms among Hispanic women is similar to that of White women. Yet, Hispanic women reportedly have positive attitudes toward menopause, which may influence their menopausal symptom experience including gastrointestinal (GI) symptoms differently from other racial/ethnic groups. However, little is still known about their menopausal symptom experience, especially their GI symptom experience during the menopausal transition. The purpose of this secondary analysis was to explore GI symptom experience of Hispanic midlife women in the U.S. and determine the factors that are correlated to their GI symptom experience. Methods This was a secondary analysis of the data among 255 Hispanic midlife women from two Internet surveys. The parent studies explored the menopausal symptom experience (including GI symptoms) of midlife women from four racial/ethnic minority groups. The data were collected using the Midlife Women's Symptom Index (based on the Cornell Medical Index). Multiple instruments related to background and health characteristics were used to assess the women's characteristics. The data were analyzed using descriptive and inferential statistics including multiple logical regression and hierarchical multiple linear regression analyses. The data among 315 non-Hispanic White women were used as comparison data. Results Compared with N-H Whites, Hispanics were more likely to report weight gain (OR=1.48), but less likely to report diarrhea (OR=0.37). The significant factors linked to the prevalence of GI symptoms were family income, perceived health, pre-menopausal status, and peri-menopausal status for the prevalence (β=-0.12, -0.14, -0.40, & -0.16, respectively); and those linked to the severity of GI symptoms were education, employment, diagnosed GI disease, pre-menopausal status and peri-menopausal status (β=0.13, 0.14, 0.19, =0.38, & 0.20, respectively). Conclusion Healthcare providers need to consider Hispanic midlife women's unique GI symptom experience during the menopausal transition and its associated factors in providing care for this specific population. [ABSTRACT FROM AUTHOR]

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus enters the cells via angiotensin-converting enzyme 2 receptor; therefore, tissues expressing this receptor are potential targets for infection. Although many studies have observed gastrointestinal (GI) symptoms in coronavirus disease 2019 (COVID-19) patients, prevalence and clinical impact are still uncertain due to the heterogeneity of reports and obstacles to generalization. Methods: In this cross-sectional study, we included symptomatic patients requiring hospital admission, with a confirmed diagnosis of COVID-19 by nasopharyngeal polymerase chain reaction test, between 18 March and 30 May 2020. Demographic data, symptoms at onset, vital signs, and laboratory tests at admission were recorded. Results: In all, 300 patients were included (57%M, 43%F). GI symptoms were mainly diarrhea (13%), anorexia (4.3%), vomiting (3%), and abdominal pain (2.3%). Overall, males were younger (68 years versus 76 years; p = 0.01); patients with GI manifestations at disease onset required significantly faster hospital admission and showed larger GI complication rates. GI symptoms were associated with abnormal high aspartate aminotransferase and alanine aminotransferase serum titers, especially in male patients. Conclusion: Our study on an Italian population during the outbreak of the COVID-19 pandemic shows that GI symptoms are part of the spectrum of the SARS-CoV-2 infection and could be the only manifestations at disease onset. Although patients with GI symptoms were associated with faster hospital admission and liver involvement, prognosis was not affected. [ABSTRACT FROM AUTHOR]

The prevalence of functional gastrointestinal (FGI) symptoms and irritable bowel syndrome (IBS) is high in the society, but the etiology is mainly unknown. This population-based, cross-sectional study aimed to examine the associations between self-reported IBS or gastrointestinal (GI) symptoms within the past 2 weeks and concomitant diseases, drug consumption and family history of diseases. Participants from the Malmö Offspring Study (MOS) answered a questionnaire about lifestyle habits, medical history and GI symptoms. Associations between self-reported IBS or GI symptoms and other diseases, drugs, and family history of diseases were calculated by logistic regression, adjusted for false discovery rate (FDR; q < 0.05). Of 2648 included patients, 316 had IBS and 459 had GI symptoms. There was an association between IBS and asthma (OR: 1.66; 95% confidence interval [CI]: 1.19–2.32; q = 0.018), and between IBS and using of prescription (OR: 1.44; 95% CI: 1.10–1.89; q = 0.028) and nonprescription drugs (OR: 1.92; 95% CI: 1.43–2.59; q < 0.001), specifically adrenergic beta-antagonists, antihistamines and hypnotics. Regarding family history, GI disease in the family (OR: 2.44; 95% CI: 1.78–3.35; q < 0.001) and the subgroups celiac disease, gastric ulcer, functional dyspepsia, IBS and reflux, as well as prostate cancer were associated with IBS, while GI diseases (OR: 2.56; 95% CI: 1.89–3.46; q < 0.001), joint diseases (OR: 1.61; 95% CI: 1.19–2.16; q = 0.009), and myocardial infarction (OR: 1.48; 95% CI: 1.09–2.99; q = 0.043) were associated with GI symptoms. Abdominal pain was the specific symptom with strongest associations. IBS and GI symptoms were mainly associated with GI diseases in the family and drug consumption. To take a family and drug history is pertinent to all clinical history taking, irrespective of the symptomatology. [ABSTRACT FROM AUTHOR]

Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) can cause gastrointestinal (GI) symptoms that often correlate with the severity of COVID‐19. Here, we explored the pathogenesis underlying the intestinal inflammation in COVID‐19. Plasma VEGF level was particularly elevated in patients with GI symptoms and significantly correlated with intestinal edema and disease progression. Through an animal model mimicking intestinal inflammation upon stimulation with SARS‐CoV‐2 spike protein, we further revealed that VEGF was over‐produced in the duodenum prior to its ascent in the circulation. Mechanistically, SARS‐CoV‐2 spike promoted VEGF production through activating the Ras‐Raf‐MEK‐ERK signaling in enterocytes, but not in endothelium, and inducing permeability and inflammation. Blockage of the ERK/VEGF axis was able to rescue vascular permeability and alleviate intestinal inflammation in vivo. These findings provide a mechanistic explanation and therapeutic targets for the GI symptoms of COVID‐19. Synopsis: VEGF is a key factor in vascular permeability and inflammation. A correlation between VEGF and COVID‐19‐related GI symptoms was established: upon viral spike protein‐induced ERK activation, VEGF was produced by the enterocytes, which led to inflamed and leaky gut. VEGF secretion positively correlated with the occurrence of GI symptoms and COVID‐19 severity, making it a key factor to predict disease progression.VEGF production was induced by SARS‐CoV‐2 spike RBD through the Ras‐Raf‐MEK‐ERK pathway in enterocytes.Blocking either ERK or VEGF relieved intestinal inflammation and leakage induced by spike both in vitro and in vivo. [ABSTRACT FROM AUTHOR]

Background - Individuals with ASD have higher than expected rates of medical conditions including gastrointestinal problems. There in paucity of research of association between gastrointestinal and behavioral problems in ASD. Objectives - To study the prevalence of gastrointestinal symptoms in children diagnosed with ASD and the association between gastrointestinal symptoms, autistic symptoms, behavior and sleep symptoms. Methods– It is a cross sectional study of 58 children and adolescents with ASD referred to our child clinic for disability assessment. Indian Scale for Assessment of Autism (ISAA) was applied and IQ assessment was done. Presence of gastrointestinal (GI) symptoms based on ROME 4 criteria was documented. Behavior Problems Inventory (BPI) and abbreviated Children’s Sleep Habit Questionnaire (CSHQ) scales were used to assess behavioral issues and sleep behavior respectively. Results - 34.5% of the study participants had gastrointestinal(GI) symptoms. Constipation was the most common GI symptom (60%) followed by abdominal pain (35%) and abdominal pain associated with bowel symptoms (15%). Those children with GI symptoms had lower age of diagnosis of ASD and higher family history of autoimmune disorders. Children with GI symptoms had higher autism scores, lower mean IQ, higher behavioral problems including higher self injurious behavior and aggression. Total sleep issues including sleep behavior problems and night waking were higher among children with GI symptoms. They also had a higher history of preterm delivery and family history of autoimmune diseases. Conclusion- There is a high prevalence of gastrointestinal symptoms in children with ASD. Those with GI symptoms have higher autism severity, behavior problems and sleep issues. Further research is warranted in this area to understand this association, which may pave way for developing specific treatment options. [ABSTRACT FROM AUTHOR]

Abstract Background Crimean-Congo haemorrhagic fever (CCHF) is a potentially fatal disease endemic in Pakistan. The causative virus is transmitted by the bite of Hyalomma ticks or by contact with infected blood or tissue. First cases of the disease were reported in Pakistan in 1976 but regular outbreaks have been observed since the year 2000. A huge agricultural base with more than 175 million livestock, the concomitant presence of Hyalomma ticks and a lack of precautionary measures to prevent transmission lead to a considerable risk for exposed populations to contract CCHF in Pakistan. At the same time, secondary cases contracted by nosocomial transmission are reported from hospitals. Case presentation Here we present an outbreak of CCHF with four of six patients succumbing to the disease before the suspicion for CCHF was raised. Importantly, the main clinical features of these cases were gastrointestinal symptoms without any clinical signs of bleeding. Only the last two patients in this outbreak presented with typical signs of bleeding disorder and were then confirmed being infected by CCHF. Confirmation of diagnosis was done at the National Institute of Health by real-time RT-PCR. Conclusions This case series highlights the importance of early clinical suspicion for CCHF in exposed individuals and the need for improved precautionary measures against the spread of CCHF within the Pakistani population and hospitals.

Background Patients with COVID-19 usually manifest fever and respiratory symptoms. However, some patients also experience gastrointestinal (GI) symptoms such as diarrhea, vomiting and abdominal pain. In addition, SARS-CoV-2 RNA has been detected in feces of infected patients. Currently there is huge evolving research interest in this potentially lethal disease. We systematically reviewed and meta-analyzed the evidence suggesting involvement of the digestive system in COVID-19. Methods PubMed, Medline and Embase databases were searched up to 10 April 2020, using suitable keywords. Individual and pooled prevalence rates with 95% confidence intervals (CI) were calculated using the fixed- or random-effects model as appropriate. Heterogeneity between studies was calculated employing the Cochran Q test and I2 values, whereas the possibility of publication bias was examined by constructing funnel plots. Additionally, subgroup and sensitivity analyses were performed. Results In adult COVID-19 patients, the prevalence rates (95%CI) for all GI symptoms, and separately for diarrhea, nausea/vomiting, and abdominal discomfort/pain were 9.8% (6.4-14.7), 10.4% (95%CI 7.7-13.9), 7.7% (95%CI 4.8-12.1), and 6.9% (95%CI 3.9-11.9) respectively. The prevalence rates for children were 9.6% (95%CI 6.3-14.3) for all symptoms, 9.6% (95%CI 6.3-14.3) for diarrhea, and 6.8% (95% CI 4.2-11) for nausea/vomiting. In 30.3% (95%CI 10.5-61.6) of the patients SARS-CoV-2 RNA was detected in feces. Conclusions A percentage of patients with COVID-19 will manifest symptoms from the digestive system. The GI tract may be a target organ and potential transmission route of SARS-CoV-2, with important implications for disease management and transmission. [ABSTRACT FROM AUTHOR]

Abstract Objectives We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill. Trial design This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design. Participants Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding Intervention and comparator Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days. Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days. Main outcomes The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization. Randomization An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization. Blinding (masking) All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment. Numbers to be randomized (sample size) A total of 84 participants will be randomized into two groups of 42 patients. Trial Status The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “ IRCT20200506047323N1 ”. Registration date is 23 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Abstract: Background: End‐of‐day questionnaires, which are considered the gold standard for assessing abdominal pain and other gastrointestinal (GI) symptoms in irritable bowel syndrome (IBS), are influenced by recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments in the natural state and environment of a subject, and herewith overcomes these limitations. This report describes the development of a patient‐reported outcome measure (PROM) based on the ESM principle, taking into account content validity and cross‐cultural adaptation. Methods: Focus group interviews with IBS patients and expert meetings with international experts in the fields of neurogastroenterology & motility and pain were performed in order to select the items for the PROM. Forward‐and‐back translation and cognitive interviews were performed to adapt the instrument for the use in different countries and to assure on patients’ understanding with the final items. Key results: Focus group interviews revealed 42 items, categorized into five domains: physical status, defecation, mood and psychological factors, context and environment, and nutrition and drug use. Experts reduced the number of items to 32 and cognitive interviewing after translation resulted in a few slight adjustments regarding linguistic issues, but not regarding content of the items. Conclusions and Inferences: An ESM‐based PROM, suitable for momentary assessment of IBS symptom patterns was developed, taking into account content validity and cross‐cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow. [ABSTRACT FROM AUTHOR]

Purpose: To provide evidence-based guidelines for early enteral nutrition (EEN) during critical illness.Methods: We aimed to compare EEN vs. early parenteral nutrition (PN) and vs. delayed EN. We defined "early" EN as EN started within 48 h independent of type or amount. We listed, a priori, conditions in which EN is often delayed, and performed systematic reviews in 24 such subtopics. If sufficient evidence was available, we performed meta-analyses; if not, we qualitatively summarized the evidence and based our recommendations on expert opinion. We used the GRADE approach for guideline development. The final recommendations were compiled via Delphi rounds.Results: We formulated 17 recommendations favouring initiation of EEN and seven recommendations favouring delaying EN. We performed five meta-analyses: in unselected critically ill patients, and specifically in traumatic brain injury, severe acute pancreatitis, gastrointestinal (GI) surgery and abdominal trauma. EEN reduced infectious complications in unselected critically ill patients, in patients with severe acute pancreatitis, and after GI surgery. We did not detect any evidence of superiority for early PN or delayed EN over EEN. All recommendations are weak because of the low quality of evidence, with several based only on expert opinion.Conclusions: We suggest using EEN in the majority of critically ill under certain precautions. In the absence of evidence, we suggest delaying EN in critically ill patients with uncontrolled shock, uncontrolled hypoxaemia and acidosis, uncontrolled upper GI bleeding, gastric aspirate >500 ml/6 h, bowel ischaemia, bowel obstruction, abdominal compartment syndrome, and high-output fistula without distal feeding access. [ABSTRACT FROM AUTHOR]

Anaplastic lymphoma kinase (ALK) gene fusions occur in 3%-7% of non-small-cell lung cancer (NSCLC) cases. Ceritinib, a once-daily, oral ALK inhibitor, has activity against crizotinib-resistant and crizotinib-naïve NSCLC, including brain metastases. Ceritinib (Zykadia™) was granted accelerated approval by the US Food and Drug Administration in 2014 for treating crizotinib-resistant ALK-positive NSCLC. Adverse events (AEs), particularly gastrointestinal (GI) AEs, are commonly experienced at the recommended dose of 750 mg/d and ~38% of patients require dose interruption or reduction for GI AEs. This case study details our experience with the use of proactive GI AE management regimens in patients treated with ceritinib (750 mg/d) across two study sites. Proactive Regimens A and B were implemented in patients with metastatic ALK-positive NSCLC treated with ceritinib to manage drug-related GI AEs. Regimen A comprised ondansetron and diphenoxylate/atropine or loperamide, taken 30 minutes prior to ceritinib dose. Regimen B included dicyclomine (taken with the frst ceritinib dose), ondansetron (taken 30 minutes prior to ceritinib dose for the frst seven doses), and loperamide (taken as needed with the onset of diarrhea). The proactive medications were tapered off depending on patient tolerability to ceritinib. Nine patient cases are presented. Starting Regimens A or B before the frst dose of ceritinib, or as soon as GI symptoms were encountered, prevented the need for dose reduction due to GI toxicity in eight of the nine patients. Using these regimens, 78% of patients were able to remain on 750 mg/d fasting. Two patients received 23 months and 16 months of therapy and remain on ceritinib 750 mg/d and 600 mg/d, respectively. Although not currently recommended or implemented in clinical studies, based on the patients evaluated here, upfront or proactive treatment plans that address AEs early on can allow the majority of patients to remain on the approved 750 mg/d ceritinib dose. [ABSTRACT FROM AUTHOR]

Background Retrospective questionnaires are frequently used for symptom assessment in irritable bowel syndrome ( IBS) patients, but are influenced by recall bias and circumstantial and psychological factors. These limitations may be overcome by random, repeated, momentary assessment during the day, using electronic Experience Sampling Methodology ( ESM). Therefore, we compared symptom assessment by ESM to retrospective paper questionnaires in IBS patients. Methods Twenty-six IBS patients (Rome III) were included, of which 16 were diagnosed with panic disorder ( DSM- IV- TR). Patients scored symptoms using end-of-day diaries during 14 days and the gastrointestinal symptom rating scale ( GSRS) once. ESM was used on seven consecutive days during the same time period. Key Results End-of-day diary abdominal pain scores were 0.4 ( SE 0.1, p < 0.001) point higher (on a 1-to-5-point scale) compared to corresponding ESM mean-scores in IBS patients. The difference was even more pronounced for upper abdominal pain scores assessed by the GSRS (4.77 ± 1.50) compared to ESM mean-scores (2.44 ± 1.30, p < 0.001), both on 1-to-7-point scale. For flatulence, comparable results were found. Nausea and belching scores showed small, but significant differences between end-of-day diary and ESM. All tested symptoms were scored higher on GSRS compared to ESM mean-scores ( p < 0.01). Affective comorbidity did not influence differences in pain reporting between methods. Conclusions & Inferences IBS patients report higher scores for abdominal pain in retrospective questionnaires compared to ESM, with a tendency to report peak rather than average pain scores. ESM can provide more insight in symptom course and potential triggers, and may lead to a better understanding of IBS symptomatology. [ABSTRACT FROM AUTHOR]