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Uncertainty exists re risk:benefit of proximal intestinal exclusion with EB, a novel endoscopic duodenal jejunal liner device for obesity, both with and without diabetes. In view of this, during 2017, an independent, secure, on line registry was established under the auspices of the Association of British Clinical Diabetologists, for the collection of safety and efficacy data worldwide. As of December 2021, data had been entered on 10patients {age 52.1 ± 10.3 year, 53% male, 87% diabetes, BMI 41.1 ± 8.9 kg/m2} and showed many benefits (Table 1) . There were 43 (4.2%) SAEs and 139 (13.9%) less serious AEs (Table 2) . All SAE patients made a full recovery and most derived significant benefit. The benefits of EB therapy are likely to reduce the complications of diabetes. This international data from the EB registry suggests that the likely benefits of EB, far outweigh the risks Disclosure R.E.J. Ryder: None. J.P. Teare: None. A. Ruban: None. M. Haluzik: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Abbott Diabetes, AstraZeneca, Lilly Diabetes, Novartis AG. L. Munro: None. H. Frydenberg: None. J.J. McMaster: None. S. Fishman: None. R.V. Cohen: Advisory Panel; GI Dynamics. Research Support; Johnson & Johnson, Medtronic. C.M. Aboud: None. G.J. Holtmann: Research Support; AbbVie Inc., Allergan, Arena Pharmaceuticals, Inc., Bayer, Bristol Myers, Datapharm Australia Pty Ltd Commonwealth Laboratories, Pty Limited, Eli Lilly Australia Pty Limited, F.Hoffmann-La Roche Limited, Falk Foundation, Falk GmbH and Co Kg, GI Therapies Pty Ltd, Gilead Sciences Pty Limited, MedImmune Ltd Celgene Pty Limited, Mylan, Nestle Pty Ltd, Prometheus Laboratories, Quintiles Pty Limited, Servatus, Takeda Development Center Asia, Pty Ltd, Vital Food Processors Ltd. C. de Jonge: None. J. Greve: Advisory Panel; GI Dynamics. Other Relationship; Bariatric Solutions International, Ethicon, Inc. J.C. Mason: None. H. Sourij: Advisory Panel; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Daiichi Sankyo, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk. Research Support; Boehringer Ingelheim International GmbH, Sanofi. Speaker's Bureau; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk. R. Drummond: Research Support; Fractyl Health, Inc. Speaker's Bureau; AstraZeneca, Bristol-Myers Squibb Company. B. McGowan: Advisory Panel; Johnson & Johnson, Lilly, Novo Nordisk. Research Support; Novo Nordisk. Speaker's Bureau; AstraZeneca, Novo Nordisk. Stock/Shareholder; Reset Health. S.A. Amiel: Advisory Panel; Medtronic, Novo Nordisk. Other Relationship; Sanofi. M. Yadagiri: None. P. Sen Gupta: None. K. Laubner: None. J. Seufert: Advisory Panel; Abbott, Sanofi-Aventis Deutschland GmbH. Research Support; Boehringer Ingelheim International GmbH. Speaker's Bureau; Abbott Diabetes, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Lilly, Novo Nordisk, Sanofi-Aventis Deutschland GmbH. Funding Association of British Clinical Diabetologists

Controversies exist regarding the benefits and most appropriate approach for preprocedural coronavirus disease 2019 (COVID-19) testing (eg, rapid antigen test, polymerase chain reaction, or real-time polymerase chain reaction) for outpatients undergoing diagnostic and therapeutic procedures, such as GI endoscopy, to prevent COVID-19 infections among staff. Guidelines for protecting healthcare workers (HCWs) from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from outpatient procedures varies across medical professional organizations. This study provides an evidence-based decision support tool for key decision-makers (eg, clinicians) to respond to COVID-19 transmission risks and reduce the effect of personal biases.A scoping review was used to identify relevant factors influencing COVID-19 transmission risk relevant for GI endoscopy. From 12 relevant publications, 8 factors were applicable: test sensitivity, prevalence of SARS-CoV-2 in the population, age-adjusted SARS-CoV-2 prevalence in the patient cohort, proportion of asymptomatic patients, risk of transmission from asymptomatic carriers, risk reduction by personal protective equipment (PPE), vaccination rates of HCWs, and risk reduction of SAE by vaccination. The probability of a serious adverse event (SAE), such as workplace-acquired infection resulting in HCW death, under various scenarios with preprocedural testing was determined to inform decision-makers of expected costs of reductions in SAEs.In a setting of high community transmission, without testing and PPE, 117.5 SAEs per million procedures were estimated to occur, and this was reduced to between .079 and 2.35 SAEs per million procedures with the use of PPE and preprocedural testing. When these variables are used and a range of scenarios are tested, the probability of an SAE was low even without testing but was reduced by preprocedural testing.Under all scenarios tested, preprocedural testing reduced the SAE risk for HCWs regardless of the SARS-CoV-2 variant. Benefits of preprocedural testing are marginal when community transmission is low (eg, below 10 infections a day per 100,000 population). The proposed decision support tool can assist in developing rational preprocedural testing policies.

ObjectiveFunctional dyspepsia (FD) is a complex disorder, with debilitating epigastric symptoms. Evidence suggests alterations in gastrointestinal (GI) motility, visceral hypersensitivity, permeability and low-level immune activation in the duodenum may play a role. However, we still have a relatively poor understanding of how these factors interact to precipitate the onset of FD symptoms which are frequently meal related. The duodenal microbiota, in combination with specific dietary substrates, may be important mediators in disease pathophysiology; however, these interlinked factors have not been thoroughly investigated in FD.DesignEighty-six individuals (56 FD, 30 controls) undergoing endoscopy were consecutively recruited and underwent detailed clinical assessment, including upper GI symptoms, gastric emptying and dietary assessment. Duodenal biopsies were obtained aseptically, and the mucosa-associated microbiota (MAM) analysed via 16S rRNA gene amplicon sequencing.ResultsThe relative abundances of predominant members of the Firmicutes, Bacteroidota and Fusobacteriota phyla were linked to symptom burden in FD. Inverse relationships between the relative abundances ofStreptococcusandPrevotella,and the relative abundance ofVeillonellaspp with gastric emptying time, were also observed. No significant differences in long-term nutrient intake or diet quality were found between FD and controls, and there appeared to be limited association between habitual diet and duodenal MAM profiles.ConclusionThis study suggests a link between the duodenal MAM, gastric emptying and FD symptoms, and this is largely independent of long-term dietary intake.

Functional gastrointestinal disorders (FGID) are linked to a variety of potential causes, and treatments include reassurance, life-style (including diet), psychological, or pharmacologic interventions.To assess whether a multidisciplinary integrated treatment approach delivered in a dedicated integrated care clinic (ICC) was superior to the standard model of care in relation to the gastrointestinal symptom burden.A matched cohort of 52 consecutive patients with severe manifestation of FGID were matched with 104 control patients based upon diagnosis, gender, age, and symptom severity. Patients in the ICC received structured assessment and 12-weeks integrated treatment sessions provided as required by gastroenterologist and allied health team. Control patients received standard medical care at the same tertiary center with access to allied health services as required but no standardized interprofessional team approach. Primary outcome was reduction in gastrointestinal symptom burden as measured by the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS). Secondary outcome was reduction in anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).Mixed models estimated the within ICC change in SAGIS total as -9.7 (95% CI -13.6, -5.8; p 0.0001), compared with -1.7 (95% CI -4.0, 0.6; p = 0.15) for controls. The difference between groups reached statistical significance, -7.6 (95% CI -11.4, -3.8; p 0.0001). Total HADS scores in ICC patients were 3.4 points lower post-intervention and reached statistical significance (p = 0.001).This matched cohort study demonstrates superior short-term outcomes of FGID patients in a structured multidisciplinary care setting as compared to standard care.

Antimicrobial therapy improves symptoms in patients with irritable bowel syndrome (IBS), but the efficacy in functional dyspepsia (FD) is largely unknown. While FD and IBS frequently overlap, it is unknown if concomitant IBS in FD alters the response to antimicrobial therapy in FD. Thus, we aimed to assess and compare the effect of antimicrobial therapy on visceral sensory function and symptom improvement in FD patients with and without IBS.Adult patients with FD with or without IBS received rifaximin 550 mg BD for 10 days, followed by a 6-week follow-up period. The total gastrointestinal symptom score as measured by the SAGIS (Structured Assessment of Gastrointestinal Symptoms) questionnaire and subscores (dyspepsia, diarrhea, and constipation), symptom response to a standardized nutrient challenge and normalization of the glucose breath tests were measured.Twenty-one consecutive adult patients with FD and 14/21 with concomitant IBS were recruited. Treatment with rifaximin resulted in a significant (p = 0.017) improvement in the total SAGIS score from 34.7 (± 15.4) at baseline to 26.0 (± 16.8) at 2 weeks and 25.6 (± 17.8) at 6 weeks post-treatment. Similarly, compared to baseline there was a statistically significant improvement in SAGIS subscores for dyspepsia and diarrhea (all p 0.05) and effects persisted for 6 weeks post-treatment. Similarly, the symptom score (and subscores) following a standardized nutrient challenge improved significantly (p 0.001) 2 weeks post-treatment. The presence of concomitant IBS did not significantly influence the improvement of symptoms after antibiotic therapy (all p 0.5).In FD patients, the response to antimicrobial therapy with rifaximin is not influenced by concomitant IBS symptoms.

Meta-analysis is an approach to formally, systematically and quantitatively analyze multiple existing research studies and to synthesize new research findings based upon the existing data. Until the late 1970s, meta-analyses were not regularly reported in the medical literature, but since then there has been an exponential growth of meta-analyses and they are now among the most frequently cited form of research. A properly performed systematic review and meta-analysis is a very important tool in evidence-based medicine and a good understanding of the steps involved in doing a systematic review and meta-analysis is important to yield meaningful results. The purpose of this review article is to provide a brief overview about systematic reviews and meta-analyses and the underlying principles for conducting this type of research. Methodological approaches for conducting a meticulous meta-analysis are described and the important steps involved in the interpretation and presentation of meta-analysis are outlined and discussed. The key objective of this paper is to outline a step-by-step approach that is useful to all researchers, who would like to conduct their first meta-analysis. This paper also provides clinicians and researchers with the information to interpret systematic reviews and meta-analyses.

In inflammatory bowel disease (IBD), ongoing gastrointestinal (GI) symptoms consistent with coexistent functional GI disorders (FGID) might occur. It is uncertain what effect these symptoms have on health-related quality of life (HRQoL) and psychological comorbidity. The aim of the present study was to identify interrelationships among IBD, symptoms consistent with FGID, HRQoL, and psychological comorbidity.A total of 256 consecutive IBD patients had diagnoses and disease activity verified at case-note review. Patients completed a contemporaneous survey assessing HRQoL, anxiety/depression, and GI symptoms (classified by Rome III criteria).Of 162 respondents (response rate: 63%), 95 (58.6%) had Crohn's disease and 63 (38.8%) had ulcerative colitis. By Rome III criteria, 66% met criteria for at least one FGID. Those with significant (Hospital Anxiety and Depression Scale ≥ 8) anxiety and/or depression were more likely to meet criteria for coexistent FGID (78% vs 22% and 89% vs 11%, respectively; each P0.001). A "load effect" was noted, such that the number of symptoms consistent with FGID in each patient correlated positively with anxiety and depression and negatively with HRQoL. Symptoms of any coexistent FGID were highly prevalent, even in those with currently-inactive IBD (57%).Symptoms consistent with FGID are highly prevalent in IBD and correlate with greater psychological comorbidity and poorer HRQoL in a "load-dependent" fashion. Therapy directed either at symptom load or psychological comorbidity might independently improve HRQoL in IBD.

Peptic ulcer disease (PUD) usually manifests as either dyspepsia or less commonly with complications such as bleeding. Patients with bleeding ulcers are often asymptomatic until the bleeding occurs. A lack of dyspeptic symptoms might be explained by impaired visceral sensory function. The aim of this study was to assess symptom profiles and compare visceral sensory thresholds in patients with bleeding peptic ulcer (BPU) and uncomplicated PUD.A total of 30 patients with BPU, 25 with uncomplicated PUD and 32 healthy controls (HC) without dyspeptic symptoms were recruited. In ulcer patients after at least 8 weeks of ulcer treatment and an 8-hr fast, visceral sensitivity was tested using a standardized nutrient challenge with an enteral feeding solution. Five key symptoms (fullness, abdominal pain, retrosternal/abdominal burning, nausea, and regurgitation) were assessed using visual analog scales (0-100).Twenty-five of the 30 (83%, 95% confidence interval 65-94%) patients with BPU had no dyspeptic symptoms compared with none of the 25 uncomplicated PUD patients. Patients with BPU and HC had significantly lower symptom responses (BPU 127.6 +/- 24.6, HC 89.8 +/- 13.9) to the nutrient challenge than uncomplicated PUD patients (338.4 +/- 56.2, P0.0001). Patients with dyspeptic symptoms (30/55) had significantly higher symptom responses (327.3 +/- 47.8) than the 25/55 patients without symptoms (98.9 +/- 23.4, P0.0001).Most patients with BPU present without dyspeptic symptoms. Even after healing of the ulcer, patients with uncomplicated PUD have a significantly augmented symptom response to a standardized nutrient challenge compared to patients with complicated ulcers and HC. Differences in the processing of upper gastrointestinal visceral afferents may play a major role in the clinical presentation (complicated vs uncomplicated) of PUD.

A significant proportion with inflammatory bowel disease (IBD) exhibit an adverse clinical phenotype reflected in endpoints like surgery and hospitalizations. We sought to identify clinico-demographic factors associated with these adverse consequences that may be amenable to change.Over 6 months IBD patients visiting a metropolitan center were prospectively identified and given a comprehensive survey addressing patient knowledge, mental health and satisfaction with medical care along with other clinical data. Logistic regression analyses assessed for associations between clinico-demographic variables and adverse clinical endpoints (previous surgery [ever] and/or recent inpatient admission over a 16 month observation period).Of 256 IBD patients, 162 responded (response rate 63%); 95 (59%) had Crohn's disease (CD), 63 (40%) ulcerative colitis (UC), four indeterminate colitis; 53% were female. Factors associated with a greater likelihood of hospitalization included moderate/severe disease activity, psychological co-morbidity, numbers of medications and outpatient visits (odds ratio [OR] 7.09 [2.83-17.76], 4.13 [1.25-13.61], 1.26 [1.03-1.54], 1.17 [1.00-1.37] respectively; all P0.05). Post-surgical patients were more likely to have CD, more currently active disease and longer disease duration (OR 8.55 [2.43-29.4], 3.52 [1.26, 9.87], 1.14 [1.08, 1.21] respectively; all P0.02), yet were less likely to have previously seen a gastroenterologist, OR 0.25 [0.08-0.76] (P = 0.01).'At risk' patients (those previously operated, with ongoing disease activity, dissatisfaction and/or psychological comorbidities) may benefit from early identification and more intensive management. Specialist gastroenterology care appears to be under-utilized in operated patients yet may reduce future IBD morbidity.