Background: Topical corticosteroids (TS) have become standard therapy for eosinophilic esophagitis (EoE). However, a variety of drug formulations have been used for which results of histological and clinical responses may be different. We aimed at determining the short-term histologic efficacy of TS for EoE based on randomized placebo-controlled trials and to review clinical response. Methods: We searched MEDLINE, ISI Web of Science, and clinicaltrials.gov for randomized controlled trials (RCTs) on TS versus placebo for active EoE published until June 2019. Treatment effects were calculated as risk ratios (RRs) comparing histologic remission between groups. Results: Nine RCTs (6 budesonide and 3 fluticasone) involving a total of 483 participants were included. A substantial overall effect of TS on acute histologic remission (RR 12.5, 95% confidence interval 6.0–25.9) was found despite varying definitions of histologic response. Indirect comparisons between drug and formulation types showed a trend for a better histologic efficacy of budesonide (RR 13.5 vs. 10.4 fluticasone) and for the orodispersible tablet (RR 46.2 vs. 11.5 suspension, and 10.4 nebulized formula/spray), but only based on small patient numbers. Scores used for clinical response assessment were different between studies, and short-term clinical results were less impressive: significant differences favoring TS were found in 4/9 RCTs (4/6 budesonide, 0/3 fluticasone). Conclusions: TS are effective for short-term induction of histological remission in EoE with less impressive clinical response rates. The mode of drug delivery to the esophagus may be a relevant factor for the degree of histologic remission. Further trials should use uniform assessment criteria and long-term patient-centered outcomes.

BackgroundIn Helicobacter pylori (H. pylori) positive stage I gastric low-grade MALT lymphoma, eradication is the accepted first-line therapy. The role of eradication therapy in lymphoma>stage IE is still unclear. However, about 20% of patients show persistent lymphoma following successful eradication or primary H. pylori-negative lymphoma. A prospective study for salvage radiation therapy with standard 36Gy in comparison to a reduced dose of 25.2Gy is still missing.MethodsA prospective, multicentre study investigated the efficacy of eradication in H. pylori-positive gastric low-grade MALT lymphoma stages IE and II1E (HELYX I). Refractory lymphoma or H. pylori-negative patients were treated in a prospective, randomised, multicentre, phase II study to receive either 25.2Gy or 36Gy radiotherapy (HELYX II).Results102 patients (3 drop outs) were included in HELYX I: 75/99 (75.8%) showed complete remission after a median of 2.8months. 18 (18.2%) had partial remission (PR) and 6 (6.0%) no change (NC). 29 patients (7 drop outs) were randomized in HELYX II (7 primarily H. pylori-negative, 15 patients from HELYX I with refractory disease after eradication). All patients achieved stable CR irrespective of radiation dose. Both presence of the t(11,18) translocation (OR 9.0, p=0.01) and monoclonality of the tumour cells (OR 6.3, p=0.006) were predictors for persistant lymphoma after eradication therapy.ConclusionsMost H. pylori-positive low grade gastric MALT lymphoma stage IE and II1E respond with stable CR after eradication therapy. In patients with refractory disease or H. pylori negative low grade gastric MALT lymphoma a dosage-reduced radiation therapy with 25.2Gy is an effective standard dose in stage IE and II1E.Trial registrationClinicalTrials.gov: NCT00154440.

BackgroundBismuth quadruple therapy (BQT) has been proven superior to standard triple therapy for Helicobacter pylori eradication in randomized clinical trials; however, little is known about the efficacy of BQT in daily routine practice. MethodsIn a single-center cohort study, we analyzed consecutive H.pylori-positive patients in whom three-in-one capsule BQT (Pylera((R)) + omeprazole) has been prescribed. All patients were instructed in a standardized fashion, and a prospective follow-up was planned. PCR on gastric biospies for clarithromycin and levofloxacin resistance was performed before treatment in a subgroup of patients. Treatment outcome was assessed by 13C urea breath test or by histology not earlier than 4weeks after end of treatment. ResultsThree-in-one capsule BQT has been prescribed in 322 patients. Approximately 70.2% of patients had a migrational background. PCR results were available in 163 patients and identified resistance to clarithromycin and levofloxacin in 29 (17.8%) and 20 (12.3%) of cases, respectively. BQT was prescribed as first-line, second-line, and salvage treatments in 74%, 17%, and 9% of cases, respectively. Five patients discontinued treatment due to side effects (1.8%). By modified intention-to-treat and per-protocol analyzes, the overall H.pylori eradication rates were 95.0% (95% CI 94.92%-95.08%) and 96.7% (95% CI 94.6%-98.8%), respectively. The low number of treatment failures (n=9) did not allow to identify risk factors for failure. ConclusionThree-in-one capsule bismuth quadruple therapy is effective and safe for treatment of H.pylori infection in routine practice, irrespective of the patient's migrational background or the number of previous treatment failures.

Hintergrund: Die Bismut-Quadrupeltherapie (BQT) ist in Deutschland seit 1/2013 für die Behandlung der H. pylori Infektion zugelassen und wird in der aktualisierten DGVS-Leitlinie 2016 als Erstlinientherapie und als Zweitlinientherapie nach Versagen der Standardtripeltherapie empfohlen. Über die Effektivität der BQT im Praxisalltag außerhalb klinischer Studien ist bislang wenig bekannt.

Hintergrund und Fragestellung: Die komplette und sorgfältige Koloskopie ist ein Schlüsselfaktor für eine wirksame Darmkrebsprävention. Das Ziel der Studie war es, die Qualität der präventiven und kurativen Koloskopie in einer definierten Gesundheitsregion in Ostsachsen (Carus Consilium Sachsen) zu evaluieren.

Background: Moxifloxacin triple therapy (MTT) has shown promising results in first-line and rescue therapy of H. pylori infection.Aims: To systematically review the efficacy and tolerability of MTT for first-line and rescue treatment of H. pylori infection, and to compare MTT with standard triple therapy (STT) and with bismuth quadruple therapy (BQT), respectively.Methods: By searching PubMed and the Cochrane Central Registry of Controlled Trials, randomized controlled trials (RCT) and other studies reporting eradication rates of MTT were identified.Metaanalyses of RCT comparing first-line MTT with STT and RCT comparing rescue MTT with BQT were performed and pooled intention-to-treat eradication rates and risk ratios (RR) with 95% confidence intervals were calculated.Results: We identified 16 studies (2481 patients) including three RCT comparing MTT with STT and five RCT comparing MTT with BQT.Pooled estimates revealed similar efficacy (RR 1.06; 0.91-1.23)and similar tolerability (RR 0.61; 0.25-1.48) of first-line MTT and STT.Rescue MTT was superior over BQT in terms of efficacy (RR 1.20; 1.07-1.36)and tolerability (RR 0.41; 0.25-0.67).Considering all MTT arms, the ITT eradication rate was 79% (72-86%) in first-line therapy and 77% (72-82%) in rescue therapy.The adverse event rate of MTT was 18.5% in first-line therapy and 18.7% in rescue therapy.Conclusions: Moxifloxacin triple therapy is superior to bismuth quadruple therapy for rescue treatment of H. pylori infection, but does not appear to offer an advantage over standard triple therapy in firstline treatment.

HAT participants underwent weekly self-testing.Self-testing consisted of answering questions regarding disease activity, adherence, side effects, and measurement of weight.An educational curriculum was delivered at the end of each session.Alerts and action plans were generated based on the results.The BAC arm underwent routine follow up, received written action plans and were given educational fact sheets.Seo Index and IBDQ scores were measured every 4 months for 1 year.Intention to treat analyses and analyses of trial completers using all available data were performed.Results: 25 patients were randomized to UC HAT and 22 to BAC.At baseline, 56% of UC HAT participants were on immune suppressants (IS) compared to 27% in BAC (p=0.05).BAC participants had higher QoL scores (191 vs. 172, p=0.02) and lower depression scores (16 vs. 21, p=0.01) than UC HAT at baseline.After 12 months, 11 (44%) participants withdrew in UC HAT compared to 5 (24%) in BAC.Disease activity, QoL, and adherence were not significantly different between groups at any time point post baseline in intention to treat analyses.An analysis of trial completers adjusting for baseline QoL showed that UC HAT participants had a decrease in Seo index scores of 11.9+/-6.6 points from baseline (p=0.08)compared to 1.2+/-6.0 in BAC (p=ns).Analysis of trial completers, adjusting for baseline disease knowledge, demonstrated improved QoL in UC HAT participants compared to BAC at 12 months (+12.5+/-5.9 vs. -3.8+/-5.3).The difference in IBDQ scores at 12 months from baseline between groups was 16.3+/-7.9(p= 0.04).Conclusions: UC HAT did not improve disease activity or QoL compared to BAC after 1 year.However, UC HAT participants demonstrated improvements from baseline in disease activity and QoL in analyses of trial completers.Our results suggest a potential benefit of UC HAT.Further research is indicated to determine if telemedicine improves outcomes in patients with IBD.

Background: Triple therapy with a proton pump inhibitor, moxifloxacin, and amoxicillin has been proven effective in first-line treatment of Helicobacter pylori infection. Aim: To explore 1, the value of triple therapy with esomeprazole, moxifloxacin, and amoxicillin in second-line or rescue treatment of Caucasian patients and 2, the impact of treatment duration on eradication success. Methods: H. pylori-infected patients with at least one previous treatment failure were randomized to oral esomeprazole 20 mg b.i.d., moxifloxacin 400 mg o.d., and amoxicillin 1000 mg b.i.d. for either 7 (EMA-7) or 14 days (EMA-14). Eradication was confirmed by 13C urea breath test. Antimicrobial susceptibility testing was performed in all patients at baseline and in patients who failed treatment. Results: Eighty patients were randomized, and 60% had ≥2 previous treatment failures. Pretreatment resistance against clarithromycin and metronidazole was found in 70.5 and 61.5% of cases, respectively. The intention-to-treat eradication rate was significantly higher after EMA-14 compared with EMA-7 (95.0 vs 78.9%, p = .036). No independent risk factor for treatment failure could be identified. There were no serious adverse events. Five of the EMA-14 patients (12.5%) compared with none of the EMA-7 patients discontinued prematurely because of adverse events (p = .031). Post-treatment resistance against moxifloxacin was found in one of seven patients with isolated organisms (14.3%). Conclusion: Second-line/rescue H. pylori eradication therapy with esomeprazole, moxifloxacin, and amoxicillin is very effective and well tolerated. Fourteen days of treatment significantly increase the eradication rate but also the rate of adverse events.

This guideline updates a prior consensus recommendation of the German Society for Digestive and Metabolic Diseases (DGVS) from 1996. It was developed by an interdisciplinary cooperation with representatives of the German Society for Hygiene and Microbiology, the Society for Pediatric Gastroenterology and Nutrition (GPGE), and the German Society for Rheumatology. The guideline is methodologically based on recommendations of the Association of the Scientific Medical Societies in Germany (AWMF) for providing a systematic evidence-based S 3 level consensus guideline and has also implemented grading criteria according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) process. Clinical applicability of study results as well as specifics for Germany in terms of epidemiology, antibiotic resistance status, diagnostics, and therapy were taken into account.

Background & Aims: Budesonide is effective in treating collagenous colitis, but no treatment is established for lymphocytic colitis. We performed a randomized, double-blind, placebo-controlled study to evaluate the effects of budesonide in patients with lymphocytic colitis. Methods: Forty-two patients (median age, 61 years) with lymphocytic colitis and chronic diarrhea were randomly assigned to groups that were given oral doses of budesonide (9 mg/d) or placebo for 6 weeks. Nonresponders at week 6 were given openlabel budesonide (9 mg/d) for 6 additional weeks. A complete colonoscopy and histologic and quality-oflife analyses were performed at baseline and at week 6. The primary end point was clinical remission at 6 weeks, with last observation carried forward (LOCF). All patients who left the study in clinical remission were followed for relapse. Results: At week 6, 86% of patients given budesonide were in clinical remission (with LOCF) compared with 48% of patients given placebo (P .010). Furthermore, open-label budesonide therapy induced clinical remission in 7 of 8 patients given placebo. Histologic remission was observed in 73% of patients given budesonide compared with 31% given placebo (P .030). Only 1 patient discontinued budesonide therapy prematurely. During a mean follow-up period of 14 months, 15 patients (44.1%) experienced a clinical relapse (after a mean of 2 months); 8 of the relapsing patients were retreated with and responded again to budesonide. Conclusions: Budesonide effectively induces clinical remission in patients with lymphocytic colitis and significantly improves histology results after 6 weeks. Clinical relapses occur but can be treated again with budesonide.

GavDALiq and Control respectively.Median time (min) to first perception of cooling was 0.57, 1.03, 0.45 and >30 for GavLiq, GavAdv, GavDALiq and Control respectively.Conclusion: The dual stopwatch method was shown to be suitable for use in assessing relief from HB by timing onset of the subjective sensorial effects of soothing and cooling in this pilot study.The three Gaviscon® products evaluated displayed fast onset (<1.5 min) of soothing and cooling effects on the esophagus during an episode of post-prandial HB induced by a standardised refluxogenic meal. M1900 Intragastric pH Holding Time pH <3 At Steady State in Healthy Volunteers (HV) After Once Daily PPIs: A Predictor for Low Erosive Esophagitis (EE)Healing Rates?Yuhong Yuan, Richard H. Hunt Background: There are still unmet needs for acid related disorders with current "delayedrelease" (DR) PPIs.We have proposed that intragastric acid suppression especially mean % pH >4 can predict healing of EE with antisecretory agents.1However, little is known of the intragastric pH holding time below pH 3 for standard dose DR-PPIs.We hypothesize that this measure may predict EE non-healing rates.Methods: A comprehensive computer-aided literature search was conducted (PUBMED and MEDLINE to Feb.2008) for published, English-language pharmacodynamic studies of intragastric acidity with standard dose, currently approved DR-PPIs given once in the morning at steady state (5-8 days) in HV, with intragastric pH obtained by pH-metry.Data for mean % pH <3 in 24hr and during the night-time were collected and summarized.The corresponding EE healing data for 4 and 8 weeks was derived from RCTs and pooled by weighting the sample size.Linear and curve estimation analyses with regression were calculated.Results: In total, 19 studies (31 arms) provided data for pH <3 for 5 PPIs (n= 686) and 106 RCTs (161 arms) provided data for EE healing (n=45,964).On average, 27.8% -44.1% (6 data points) and 36.1% -65.7% (5 data points) for 24hr and night-time periods showed a pH <3 after standard dose PPIs for 5-8 days, respectively; the corresponding EE non-healed rate was 26.8% -34.6% at 4 weeks (5 data points) 14.4% -19.5% at 8 weeks (6 data points) (table ).The trend increased with holding time of pH <3/24 hr and with the 8 week EE non-healed rate; with a significant correlation observed in the linear (r=0.82,p=0.044), growth model (r=0.84,p=0.036) and exponential model (r=0.84,p=0.036).Conclusions: When standard dose DR-PPIs are given once in the morning in healthy volunteers for 5-8 days, between 28% and 44% of the 24 hr and between 36% and 66% of the night-time show a pH <3, respectively, which clearly demonstrates an unmet need of current DR-PPIs.Any increase in the pH <3 holding time in the 24 hr is associated with an increase in the EE non-healed rate at 8 weeks.Intragastric pH holding time <3 might be a good predictor for the EE non-healing rate although prospective studies are needed.1.

Aim: To investigate a 1-week once-daily triple therapy with esomeprazole, moxifloxacin, and rifabutin for rescue therapy of Helicobacter pylori infection.Methods: Consecutive patients (n = 103) with at least one previous treatment failure and H. pylori infection resistant to both metronidazole and clarithromycin were treated with esomeprazole 40 mg, moxifloxacin 400 mg, and rifabutin 300 mg, given once daily for 7 days. Eradication was confirmed by histology and culture. CYP2C19 status was determined by polymerase chain reaction-restriction fragment length polymorphism.Results: Intention-to-treat and per-protocol eradication rates were 77.7% (68.4-85.3) and 83.3% (74.4-90.2). Five patients discontinued prematurely (4.8%). Eradication was achieved in 93.1% of poor/intermediate metabolizers and in 78.8% of homozygous extensive metabolizers (p = .14). Eradication rates in patients with one, two, three, and four or more previous failures were 78.3%, 89.6%, 68.6%, and 88.9%, respectively (p = .21). The regimen was effective in seven of nine patients who previously failed quadruple therapy. Post-treatment resistance to moxifloxacin and rifabutin was detected in two (12.5%) and five (31%) patients after treatment failure.Conclusion: Once-daily triple therapy with esomeprazole, moxifloxacin, and rifabutin is a promising, safe, and convenient regimen for rescue therapy of H. pylori infection that may serve as a valuable alternative to quadruple therapy, particularly for patients with intolerance to amoxicillin.