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Background and Aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason. Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars. Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6–24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p

Background Infliximab and adalimumab are widely used for the treatment of Crohn's disease and ulcerative colitis. Aim To compare the long-term efficacy and safety of infliximab and adalimumab in a large cohort of Crohn's disease and ulcerative colitis patients reflecting real-life clinical practice. Methods Seven hundred twelve patients were retrospectively reviewed, 410 with Crohn's disease (268 treated with adalimumab and 142 with infliximab; median follow-up 60 months, range, 36-72) and 302 with ulcerative colitis (118 treated with adalimumab and 184 with infliximab; median follow-up 48 months, range, 36-84). Results In Crohn's disease, clinical remission was maintained in 75.0% of adalimumab vs. in 72.5% of infliximab patients (P = 0.699); mucosal healing and steroid-free remission were maintained in 49.5% of adalimumab vs. 63.9% of infliximab patients (P = 0.077) and in 77.7% of adalimumab vs. 77.3% in infliximab group (P = 0.957), respectively. In ulcerative colitis, clinical remission was maintained in 50.0% of adalimumab vs. 65.8% of infliximab patients (P 10 were predictors of failure in Crohn's disease; treatment with adalimumab, BMI ≥30 and Mayo score >10 were predictors of failure in ulcerative colitis. infliximab was more likely to cause adverse events than adalimumab (16.6 vs. 6.2%, P Conclusion Both adalimumab and infliximab are effective in long-term outpatients management of inflammatory bowel diseases. Adalimumab had a lower rate of adverse events.

Background and Aim: The Nutritional Risk Security (NRS2002) System is recommended for hospitalized patients in order to assess their nutritional status. However, studies assessing large-scale systematic screening policies are lacking. The aim of this study was to assess the feasibility of implementing a screening strategy concerning all admissions for diverticular disease (DD) of the colon in the Department of Medicine of a Tertiary Hospital. Methods: All patients suffering from acute diverticulitis (AD) and admitted to the Medicine Department from January 1st to 31 December 2017, were pre-screened by NRS2002 System by the nursing staff of the Nutritional team at the day of the admission. If the pre-screening was positive, the patients were referred to a supplementary assessment performed by a dietician. Results: The global number of admissions in the observational period was 4,667 and 133 patients suffered from AD. A positive pre-screening test was recorded in 97 (72.9%) patients: a NRS2002 score > 3, describing a severe impaired nutritional status was found in 61 patients (62.9%). All 97 patients with a NRS2002 positive screening received initial nutritional support by oral supplements (17 patients, 17.52%) or enteral nutrition (22 patients, 22.68%) or total parenteral nutrition (58 patients, 59.8%). The mean length of hospital stay for all 133 patients was 6,9 days. However, the length of hospital stay was significantly longer for patients with a positive NRS2002, with a mean of 18 days (p= 0.01) Conclusions: A large number of hospitalized patients due to AD are at nutritional risk and have a significantly longer hospital stay.

Background Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce. We compare the efficacy and safety of ADA biosimilars SB5, ABP501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. Methods A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn’s disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti–tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. Results A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. Conclusions Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.

Patients hospitalized in internal medicine are frequently malnourished or at risk for malnutrition. The aim of this study, conducted by the Federation of Associations of Hospital Internists (FADOI) and the Italian Society of Artificial Nutrition and Metabolism (SINPE) was to assess the nutritional management of internal medicine inpatients in Italy, to identify critical issues and formulate practical proposals to improve nutritional treatment.From February to April 2021, FADOI and SINPE conducted a national web-based survey, including a 13 multiple-choice item questionnaire related to three key areas: screening and assessment of malnutrition and associated/overlapping sarcopenia and dysphagia; specialist consultations; and management of nutritional support.Responding to the questionnaire were 266 physicians among FADOI members (10.76%). Screening for malnutrition is performed with validated tests, within standardized care pathways, or routinely, only by 22% of participants. Global Leadership Initiative on Malnutrition criteria for diagnosis of malnutrition are little used (20%). Screening for sarcopenia was insufficient as the systematic use of assessment tools (handgrip/chair test) was minimal (3%). Screening for dysphagia is not a routine procedure for at-risk patients according to 33% of participants. Systematic involvement of clinical nutrition services/units in the management of malnourished/sarcopenic patients was reported by only 17% of internists.To overcome the critical issues that emerged from the present study, FADOI and SINPE experts proposed practical solutions to promote the application of the most recent guidelines and to improve awareness and sensitivity to nutritional management in internal medicine real-life settings.

article i nfo Background:Infliximab (IFX) and adalimumab (ADA) arethe key treatmentsfor Crohn'sDisease(CD),unrespon- sivetostandard treatments. Our aim wastocompare the efficacy and safety ofIFXandADAintreating CD inclin- ical practice. Methods:One hundredandtwenty-sixpatients(61 M,65F,meanage 36.2 years,range19-67 years),affectedby CD, were treated with infliximab (IFX, 59 patients) or adalimumab (ADA, 66 patients). Clinical efficacy, mucosal healing (MH), histological healing (HH), and safety were assessed. MH was defined complicated if healing of ul- cers occurred with deformation of bowel profile and/or complete colonoscopy was impossible because of scars. Results: Patients were followed-up for 36 months. No difference was found between IFX and ADA in maintaining long-term clinicalremission,MHandHH.ComplicatedMHwaspresentin17(28.8%)patientsinIFXgroupandin 7 (10.6%) patients in ADA group (p = 0.012). In 9 (15.2%) patients in IFX group and 2 (3.0%) patients in ADA group colonoscopy was incomplete without cecal intubation or terminal ileum exploration (p = 0.024). Side effects were similar in both groups. Conclusions: Both IFX and ADA seem to be effective and safe in long-term outpatient treatment of CD in clinical practice.

Aliment Pharmacol Ther 2011; 33: 358–365 Summary Background Ulcerative colitis with diverticulosis (UCD), segmental colitis associated with diverticulosis (SCAD) and acute uncomplicated diverticulitis (AUD) may affect the same colonic regions, but the real incidence of these entities in clinical practice is unknown. Aim To assess the incidence and the endoscopic findings of UCD, SCAD and AUD. Methods From January 2004 to June 2009, 8525 consecutive colonoscopies were performed. Diagnosis of the diseases was based on specific endoscopic and histological (UCD and SCAD), and on endoscopic and radiological (AUD) patterns. Results Ulcerative colitis with diverticulosis was diagnosed in 25 patients (0.3%), SCAD was diagnosed in 129 patients (2%) and AUD was diagnosed in 130 patients (2%). In UCD, the inflammation in colonic area harbouring diverticula always affects the overall colonic mucosa in all cases, involving also diverticular orifices. The endoscopic characteristic of SCAD is that inflammation is mainly detected within the inter-diverticular mucosa without involvement of the diverticular orifices. In AUD, the inflammation affects primarily diverticular orifice and peri-diverticular mucosa. Conclusions In clinical practice, the incidence of mucosal inflammation in the presence of colonic diverticular disease is low and endoscopy is the mainstay of differential diagnosis.

The term “microbiota” means genetic inheritance associated with microbiota, which is about 100 times larger than the guest. The tolerance of the resident bacterial flora is an important key element of immune cell function. A key role in the interaction between the host and the microbiota is played by Paneth cell, which is able to synthesize and secrete proteins and antimicrobial peptides, such asα/βdefensins, cathelicidin, 14β-glycosidases, C-type lectins, and ribonuclease, in response to various stimuli. Recent studies found probiotics able to preserve intestinal homeostasis by downmodulating the immune response and inducing the development of T regulatory cells. Specific probiotic strain, as well as probiotic-driven metabolic products called “postbiotics,” has been recently recognized and it is able to influence innate immunity. New therapeutic approaches based on probiotics are now available, and further treatments based on postbiotics will come in the future.

OBJECTIVE: Celiac disease is a gluten-sensitive enteropathy with a broad spectrum of clinical manifestation, and most celiac patients respond to a gluten-free diet (GFD). However, in some rare cases celiacs continue to experience GI symptoms after GFD, despite optimal adherence to diet. The aim of our study was to evaluate the causes of persistence of GI symptoms in a series of consecutive celiac patients fully compliant to GFD. METHODS: We studied 15 celiac patients (five men, 10 women, mean age 36.5 yr, range 24-59 yr) who continued to experience GI symptoms after at least 6-8 months of GFD (even if of less severity). Antigliadin antibody (AGA) test, antiendomysial antibody (EMA) test, and sorbitol H2-breath test (H2-BT), as well as esophagogastroduodenoscopy (EGD) with histological evaluation, were performed before starting GFD. Bioptic samples were obtained from the second duodenal portion during EGD, and histopathology was expressed according to the Marsh classification. To investigate the causes of persistence of GI symptoms in these patients, we performed AGA and EMA tests, stool examination, EGD with histological examination of small bowel mucosa, and sorbitol-, lactose-, and lactulose H2-breath tests. RESULTS: Histology improved in all patients after 6-8 months of GFD; therefore, refractory celiac disease could be excluded. One patient with Marsh II lesions was fully compliant to his diet but had mistakenly taken an antibiotic containing gluten. Two patients showed lactose malabsorption, one patient showed Giardia lamblia and one patient Ascaris lumbricoides infestation, and 10 patients showed small intestinal bacterial overgrowth (SIBO) by lactulose H2-BT. We prescribed a diet without milk or fresh milk-derived foods to the patient with lactose malabsorption; we treated the patients with parasite infestation with mebendazole 500 mg/day for 3 days for 2 consecutive wk; and we treated the patients with SIBO with rifaximin 800 mg/day for 1 wk. The patients were re-evaluated 1 month after the end of drug treatment (or after starting lactose-free diet); at this visit all patients were symptom-free. CONCLUSIONS: This study showed that SIBO affects most celiacs with persistence of GI symptoms after gluten withdrawal.

Anti-TNFα antibodies are effective in treating inflammatory bowel diseases (IBDs) unresponsive to the standard treatments. Information about the role of rapid fecal calprotectin (FC) in monitoring ambulatory IBD patients under treatment with anti-TNFα is lacking. Our aim was to assess the accuracy of rapid FC in monitoring those patients. Seventy-two patients (38 males, 34 females, mean age 42.5 years, range 23–57 years), affected by ulcerative colitis (UC) (20 patients) or by Crohn’s disease (CD) (52 patients) were treated with anti-TNFα antibodies. FC was assessed by a rapid semiquantitative test. With respect to the absence of clinical remission, FC test showed sensitivity of 71.8 %, specificity of 65.2 %, PPV of 41.8 %, and NPV of 86.9 %. In UC patients, FC test showed a sensitivity of 66.7 %, a specificity of 56.1 %, a PPV of 18.2 %, and a NPV of 92.0 %. In CD patients, FC test showed sensitivity of 70.6 %, specificity of 65.2 %, PPV of 50.0 %, and NPV of 81.8 %. With respect to the presence of endoscopic lesions, FC test showed sensitivity of 73.5 %, specificity of 96.0 %, PPV of 96.2 %, and NPV of 72.7 %. In UC patients, FC test showed sensitivity of 47.2 %, specificity of 84.6 %, PPV of 89.5 %, and NPV of 36.7 %. In CD patients, FC test showed sensitivity of 90.1 %, specificity of 79.7 %, PPV of 71.9 %, and NPV of 93.3 %. Diagnostic accuracy of rapid FC seems better in predicting persistence of endoscopic lesions than clinical remission in IBD patients under treatment with anti-TNFα.

Infliximab (IFX) is the key treatment for ulcerative colitis (UC) unresponsive to standard treatments. The aim of the present study was to assess the efficacy and safety of IFX in treating ambulatory UC patients in primary gastroenterology centers.One hundred and eighteen patients (65 M, 63 F, median age 34 years, range 19-71 years), affected by UC, were treated with IFX. Clinical efficacy, safety, mucosal healing (MH), and histological healing (HH) were assessed at a scheduled follow-up of 42 months.Percentage of patients with clinical remission persistence at 42-month follow-up was 70.4%. Colectomy occurred in only 3 patients (2.7%). At 42-month follow-up percentage of patients with MH was 44.6%, and percentage of patients with HH was 24.3%. HH at 6-month follow-up occurred in 13 out of 34 patients (38.2%) with C-reactive protein (CRP)3 and in 8 out of 76 patients (10.5%) with CRP ≥ 3 (p=0.002). Side effects were reported in 16 patients (13.6%): infusion reactions occurred in 7 patients, other severe side-effects occurred in 3 patients, and opportunistic infections occurred in 3 patients (2.5%). Finally, 3 cancers (2.5%) occurred during the follow-up period (1 breast, 1 kidney and 1 rectal cancer). Both univariate and multivariate analyses showed Hb11.5 g/dL and HH at 6-month follow-up to be significantly associated with treatment failure during follow-up.IFX seems to be effective and safe in long-term treatment of outpatients affected by UC.

Summary Background Placebo-controlled studies in maintaining remission of symptomatic uncomplicated diverticular disease (SUDD) of the colon are lacking. Aim To assess the effectiveness of mesalazine and/or probiotics in maintaining remission in SUDD. Methods A multicentre, double-blind, placebo-controlled study was conducted. Two hundred and ten patients were randomly enrolled in a double-blind fashion in four groups: Group M (active mesalazine 1.6 g/day plus Lactobacillus casei subsp. DG placebo), Group L (active Lactobacillus casei subsp. DG 24 billion/day plus mesalazine placebo), Group LM (active Lactobacillus casei subsp. DG 24 billion/day plus active mesalazine), Group P (Lactobacillus casei subsp. DG placebo plus mesalazine placebo). Patients received treatment for 10 days/month for 12 months. Recurrence of SUDD was defined as the reappearance of abdominal pain during follow-up, scored as ≥5 (0: best; 10: worst) for at least 24 consecutive hours. Results Recurrence of SUDD occurred in no (0%) patient in group LM, in 7 (13.7%) patients in group M, in 8 (14.5%) patients in group L and in 23 (46.0%) patients in group P (LM group vs. M group, P = 0.015; LM group vs. L group, P = 0.011; LM group vs. P group, P = 0.000; M group vs. P group, P = 0.000; L group vs. P group, P = 0.000). Acute diverticulitis occurred in six group P cases and in one group L case (P = 0.003). Conclusion Both cyclic mesalazine and Lactobacillus casei subsp. DG treatments, particularly when given in combination, appear to be better than placebo for maintaining remission of symptomatic uncomplicated diverticular disease. (ClinicalTrials.gov: NCT01534754).

Background Sequential therapy is currently suggested as first-line therapy in curing Helicobacter pylori infection, but results coming from its use in clinical practice are scarce. We evaluated the efficacy of this therapy regimen in our current clinical practice. Methods A retrospective study was conducted on 437 consecutive dyspeptic patients with proven H. pylori infection. Patients received a 10-day sequential therapy with proton pump inhibitor (PPI) plus amoxicillin 1 g for the first 5 days, followed by PPI, clarithromycin 500 mg, and tinidazole 500 mg for the remaining 5 days (all twice daily) plus PPI every day for further 4 weeks in case of active peptic ulcer or severe gastritis detected at endoscopy. One month after conclusion of therapy, endoscopy was performed in those patients for whom the examinations were clinically relevant. The remaining patients were checked by 13C-urea breath test. Results Three-hundred ninety-eight patients (91.08%; 95% confidence interval [CI], 87.91%-93.50%) were fully compliant, 19 patients (4.35%; 95% CI, 2.71%-6.83%) took less than 80% of the prescribed drugs, 11 patients (2.52%; 95% CI, 1.33%-4.60%) were withdrawn because of side effects, and 9 patients (2.06%; 95% CI, 1.01%-4.01%) were lost to follow-up. The H. pylori eradication was obtained in 395 (90.39%, 95% C.I. 87.14% to 92.91%) of 437 and in 362 of 437 (82.84%, 95% C.I. 78.90% to 86.19%) as per-protocol and intention-to-treat analyses, respectively. Conclusions Sequential regimen seems to be a valid therapeutic strategy for the management of H. pylori infection in clinical practice.

Recent studies have shown that the prevalence of anti-endomysial antibodies (EMAs) in clinical practice is lower than expected; the aim of our study was therefore to compare the sorbitol H2-breath test (BT) with EMAs in the diagnosis of subclinical/silent coeliac disease and to compare with histologic lesions.We studied 123 consecutive patients with subclinical (96) and silent (27) coeliac disease. Expiratory samples were collected before the patients drank the test solution (5 g of sorbitol in 150 ml of tap water) and every 30 min for 4 h. An increase in H2 concentration of at least 20 ppm over fasting baseline was considered positive for sorbitol malabsorption. EMAs were screened by the indirect immunofluorescence method.EMAs were positive in 77/96 (80.80%) and sorbitol H2-BT in 94/96 (97.91%) patients with subclinical coeliac disease, while EMAs were positive in 17/27 (62.96%) and sorbitol H2-BT in 26/27 (96.29%) patients with silent coeliac disease (P0.001 in both forms of coeliac disease). The best cut-off values in ppm and minutes are higher and shorter in the severe form than in the minor form of intestinal damage, respectively (P0.001 in both forms).This study indicates that almost all subclinical/silent coeliac patients show abnormal sorbitol H2-BT and that there is a strict correlation between cut-off value (in ppm and minutes) and histologic lesions. In particular, the maximal cut-off value (in ppm and in minutes) correlates statistically with the more severe the grade of intestinal damage. Finally, the prevalence of EMA in subclinical/silent disease is lower than expected.

Purpose Available literature data show that celiac disease (CD) is a frequent cause of recurrent miscarriage. However, data are lacking for pregnancy outcome when the patient is on a gluten-free diet (GFD). A case-control study about the effect of GFD on pregnancy was conducted from 1995 to 2006. A cohort of 13 women (mean age 32 years, range 22–38 years) affected by CD with recurrent miscarriages was observed. In all of them several causes of miscarriage (gynecological, endocrine, hematological, etc.) were excluded. All patients were started on a gluten-free diet and were reassessed throughout a long-term follow-up period to evaluate the outcome of pregnancy. Results Six of 13 became pregnant (46.15%) as follows: 1 patient (7.69%) 1 year after GFD was started, 3 patients (23.07%) 2 years after GFD was started, 1 patient (7.69%) after 3 years, and finally 1 (7.69%) 4 years after GFD was started. Moreover, two patients (16.66%) had multiple pregnancies (one had had two childbirths and another had undergone three births within a 7-year follow-up period under GFD). Conclusions GFD seems to favor a positive outcome of pregnancy in most CD patients with recurrent miscarriage.

Division of Gastroenterology, “Cristo Re” Hospital, Rome, ItalyTo the Editor:Fecal calprotectin (FC), assessed as enzyme-linked immunosorbent analysis (ELISA) technique,has been shown to be a sensitive marker of activity ininflammatory bowel disease (IBD) [1]. A rapid testassessing FC has been recently developed [2],accounting a diagnostic accuracy for active IBD sim-ilar to that of standard ELISA technique [3]. Despitethis, no studies assessing a correlation between rapidFC test and clinical scores of IBD severity are cur-rently available.We enrolled 137 consecutive patients, of which90 patients were affected by ulcerative colitis (UC)and 47 patients were affected by celiac disease (CD),who had undergone a total colonoscopy and in whomthe disease was diagnosed for the first time. Diseaseactivity [Disease Activity Index (DAI) [4] for UC andHarvey–Bradshaw Index (HBI) [5] for CD), endo-scopic severity (Mayo endoscopic subscore for UC[6]; a simple, arbitrary endoscopic classification toassess the endoscopic severity of CD, which is usedfor both small bowel and colon: 0–no inflammation(absence of erosions and/or ulcers, with or withoutscars); 1–mild inflammation (scattered erosions/aphthoid ulcers); 2–moderate inflammation (diffuseerosions and/or aphthoid ulcers, scattered superficialulcers); 3–severe (diffuse superficial ulcers and/or deep ulcers), and rapid FC (CAL Detect , SofarSpA, Trezzano Rosa, Milan, Italy) were assessedbefore starting therapy. Thirty patients under endo-scopicandclinicalremission(15withUCand15withCD) were used as a control group.In UC, FC score correlated either with DAI[r = 0.617, 95% confidence interval (CI) 0.470–0.731; p 60 mg/kg. However, ourstudy showed that FC values >60 mg/g strictly corre

Small intestinal lesions have a wide severity in coeliac disease (CD), and early diagnosis is important in preventing neoplastic and non-neoplastic disorders related to CD. The aim of this study was to compare the effectiveness of the sorbitol H2 breath test (H2-BT) and serological tests (antigliadin (AGA), antiendomysium (EMA) and anti-tissue transglutaminase (anti-tTG)) as screening tests in the detection and estimation of CD prevalence in 1st-degree relatives.Screening was performed in 111 1st-degree relatives of 37 coeliac families. Sorbitol H2-BT, AGA, EMA and anti-tTG antibodies were used to select the candidates for small-bowel biopsy. Relatives with abnormal serological tests and/or with sorbitol H2-BT positivity underwent a small-bowel biopsy. Small-bowel biopsy was also performed in relatives negative in all tests but with clinical complaints or suspected of having CD, and intestinal lesions were expressed according to the Marsh classification.CD was diagnosed in 49/111 screened relatives (44.14%): 5 showed Marsh IIIc, 8 Marsh IIIb, 16 Marsh IIIa, 13 Marsh II and 7 Marsh I lesions. Nineteen relatives showed the classical form of the disease, while the subclinical and silent forms were recorded in 20 and 10, respectively. AGA, EMA and anti-tTG showed strong positivity only in severe intestinal damage (Marsh IIIb-c lesions) (but overall positivity was 36.73%, 38.78% and 44.89% for AGA, EMA and anti-tTG, respectively), while sorbitol H2-BT showed strong positivity also in patients with slight histological damage (Marsh I-IIIa) (overall positivity was 83.67%).A significant proportion of coeliacs may be missed if relatives are screened by serology only, while the efficacy of sorbitol H2-BT in screening relatives is confirmed. This study confirms that neither a breath test nor serology can replace intestinal biopsy, which remains the gold standard for the diagnosis of CD.

A study on orocaecal transit time (OCTT) in patients with different localizations of Crohn's disease (CD) is not available. Because slow-release drug formulations are increasingly available for the treatment, there is a concrete risk that delayed OCTT may impair the efficacy of these formulations.We investigated OCTT before and after therapy using lactulose H2-breath test and we studied whether OCTT can influence the clinical response to therapy with slow-release mesalazine formulations in adult CD patients.(2)We studied 45 adult patients with non-obstructive CD and Crohn's Disease Activity Index (CDAI)200 (29 men, 16 women; mean age 42 years, range 22-73 years). Twenty patients had ileocolonic, 16 colonic and 9 ileal localization of CD. The control group consisted of 20 healthy subjects (13 men, seven women; mean age 53 years, range 22-71 years). After OCTT assessment, 29 patients were treated with time-dependent mesalazine 3.6 g/day, while 16 patients were treated with pH-dependent mesalazine 3.6 g/day. If bacterial overgrowth was detected, the patients were also treated with rifaximin 800 mg/day for 7 days.OCTT was delayed (120 min, range 115-210 min) in 30 of the 45 CD patients (67%). Four patients (9%) showed bacterial overgrowth, while OCTT was regular (82.5 min, range 75-90 min) in 11 patients (24%). In the control group, the mean OCTT was 88.2 min (range 75-135 min); (P0.01). OCTT was more prolonged in ileal localization (182.2 min, range 150-210 min), rather than in patients with ileocolonic (122 min, range 75-180 min) or colonic (106 min, range 75-150 min) localization of CD; (P0.01). Thirty-nine patients showed normal OCTT after starting therapy (83 min, range 75-105 min), while OCTT remained slightly delayed in the remaining patients (110 min, range 105-115 min); (P0.01). CDAI was100 (mean value 83) in all patients with reduction of OCTT to normal value 4 months after starting therapy, while it was140 (mean value 143) in patients with a slight reduction but not normalization of OCTT respectively (five patients with ileal and one with ileocolonic localization of CD) with a statistically significant correlation between OCTT and CDAI (P0.01).This study shows clearly for the first time that OCTT is not only delayed in patients with active CD, but also that it is prolonged in ileal and ileocolonic rather than colonic localization of CD. Moreover we obtained these results using a simple, sensitive, non-invasive and repeatable method, namely, a lactulose hydrogen breath test.

Ranitidine bismuth citrate has recently been introduced for the treatment of H. pylori infection and obtains good eradication rates; however, eradication failures still appear in a considerable proportion of cases. The aim of this study was to compare the efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure H. pylori infection.We studied 423 consecutive H. pylori-positive patients. In 210 consecutive patients H. pylori infection was diagnosed for the first time (group A), while 213 consecutive patients were enrolled after failure of a first attempt to eradicate H. pylori (group B). All patients received ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. and amoxycillin 1 g b.d. for seven days. H. pylori-status was evaluated by means of histology and rapid urease test at entry and by 13C-urea breath test in all patients one month after treatment.410/423 patients completed the study (202/210 in group A and 208/213 in group B). Two patients of group A and 1 patient of group B were withdrawn from the study due to poor compliance, 6 group A patients and 4 group B patients were lost to follow-up. In group A, after the end of treatment, 181/202 patients were H. pylori-negative (per-protocol analysis: 89.60% [C.I. 95%: 82-95%]; on intention-to-treat analysis: 86.19% [C.I. 95%; 76-92%]), side-effects occurred in 29 patients (13.80%); they were severe in 2 patients and the patients were withdrawn from the study. In group B, after the end of treatment, 200/208 patients were H. pylori-negative (per-protocol analysis: 95.15% [C.I. 95%; 92-100%], on intention-to-treat analysis: 93.89% [C.I. 95%; 89-98%), side-effects occurred in 11 patients (5.13%); they were slight or mild and did not require discontinuation of the treatment. The results of group B were statistically better than group A, both in eradication rate (P0.01) as well as both side-effects provoked (P0.01).Ranitidine bismuth citrate-clarithromycin-amoxycillin is more effective when used as second-line therapy rather than when used as first-line therapy; second, ranitidine bismuth citrate-clarithromycin-amoxycillin shows lower and slighter side-effects when used as second-line therapy rather than when used as first-line therapy; finally, the excellent tolerability of ranitidine bismuth citrate + clarithromycin + amoxycillin influences positively the patients' compliance, both as first- and second-line therapy.

Endomysial antibodies (EMA) are a well-known hallmark of celiac disease, but some recent studies showed that the prevalence of these antibodies in clinical practice is lower than expected. The aim of our study was to determine the prevalence of antigliadin (AGA) and EMA antibodies on a consecutive series of subclinical/silent celiac patients.We studied 115 consecutive patients with subclinical (92 patients) or silent (23 patients) forms of celiac disease. AGA and EMA were screened in all patients. Histopathology of celiac disease was expressed according to the Marsh classification.The overall AGA in subclinical form were positive in 77% (14 of 18) of patients with partial villous atrophy (VA), in 84% (21 of 25) of patients with subtotal VA, and in 90% (27 of 30) of patients with total VA, whereas EMA were positive in 88.88% (16 of 18) of patients with partial VA, in 92% (23 of 25) of patients with subtotal VA, and 96.66% (29 of 30) of patients with total VA. On the other hand, AGA were positive in 0% (zero of two) of patients with Marsh I and in 30% (three of 10) of patients with Marsh II, whereas EMA were positive in 0% (zero of two) of patients with Marsh I and in 40% (four of 10) of patients with Marsh II (Marsh I-IIIa vs Marsh IIIb-c, p =0.005 in overall AGA-positive patients and p =0.0001 in EMA-positive patients). At the same time the overall AGA in silent form were positive in 60% (three of five) of patients with partial VA, in 66.66% (four of six) of patients with subtotal VA, and in 77.77% (seven of nine) of patients with total VA, whereas EMA were positive in 80% (four of five) of patients with partial VA, in 83.33% (five of six) of patients with subtotal VA, and in 88.88% (eight of nine) of patients with total VA. On the other hand, overall AGA were positive in 0% of patients with both Marsh I (zero of one) and Marsh II (zero of two), as well as EMA were positive in 0% with both Marsh I (zero of one) and Marsh II (zero of two) (Marsh I-IIIa vs Marsh IIIb-c, p =0.001 in overall AGA-positive patients and p =0.007 in EMA-positive patients).At this time small bowel biopsy seems to be the only correct procedure to diagnose a case of suspected celiac disease, especially in patients with mild symptoms or suspected for celiac disease, because they belong to high-risk groups.

Hypochromic anemia is at times attributable to nondiagnosed celiac disease. The aim of this study was to define the correlates of celiac disease in anemic adults without overt malabsorption.One hundred patients with hypochromic anemia and without diarrhea underwent a complete diagnostic work-up, including screening for celiac disease, i.e., upper endoscopy with duodenal biopsy and search of antiendomysium antibodies.Patients with hypochromic anemia were from two different Divisions and were analyzed as a single group because they were not significantly different for any variable. Hypochromic anemia was attributable to celiac disease in 10 patients. Compared to anemic patients without celiac disease, anemic patients with celiac disease had significant or borderline significant differences for plasma cholesterol (-17.9%), albumin (-9.4%), and body mass index (-11.8%), but not for gender distribution, age, weight, height, blood hemoglobin, mean corpuscolar volume, plasma iron, and ferritin. All anemic patients with celiac disease had plasma cholesterol156 mg/100 ml. Within the entire cohort of anemic patients, plasma cholesterol inversely related to prevalence of celiac disease (p0.001); also plasma albumin and body mass index inversely related to celiac disease, but coefficients were borderline significant (p = 0.056 and 0.052, respectively).The data suggest that among patients with hypochromic anemia, plasma cholesterol in the high-to-normal range could be used to exclude the presence of celiac disease. Other nutritional markers are less sensitive as indices of risk of celiac disease. Hematological indices are not of help to define the risk of celiac disease in anemic patients without signs of malabsorption.