المؤلفون: Jonathan Golob, Krishna Rao, Jeffrey A. Berinstein, William D. Chey, Chung Owyang, Nobuhiko Kamada, Peter D.R. Higgins, Vincent Young, Shrinivas Bishu, Allen A. Lee

المصدر: Gastro Hep Advances, Vol 3, Iss 2, Pp 167-177 (2024)

مصطلحات موضوعية: Quiescent Crohn’s Disease, Hydrogen Sulfide, Tryptophan, Patient-Reported Outcomes, Gut Microbiome, Diseases of the digestive system. Gastroenterology, RC799-869

الوصف: Background and Aims: Even in the absence of inflammation, persistent symptoms in Crohn’s disease (CD) are prevalent and worsen quality of life. Amongst patients without inflammation (quiescent CD), we hypothesized that microbial community structure and function, including tryptophan metabolism, would differ between patients with persistent symptoms (qCD + S) and without persistent symptoms (qCD-S). Methods: We performed a multicenter observational study nested within the Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease. Quiescent inflammation was defined by fecal calprotectin level

وصف الملف: electronic resource

العلاقة: http://www.sciencedirect.com/science/article/pii/S2772572323001802Test; https://doaj.org/toc/2772-5723Test

الوصول الحر: https://doaj.org/article/7e340aa5233f4c398bbb6f7398d424feTest

المؤلفون: Anthony J. Lembo, Susan Edelstein, David P. Rosenbaum, Ceciel Rooker, Jeffrey D. Roberts, William D. Chey

المصدر: Therapeutic Advances in Gastroenterology, Vol 17 (2024)

مصطلحات موضوعية: Diseases of the digestive system. Gastroenterology, RC799-869

الوصف: This document provides a short summary of the T3MPO-3 study, which was published in Neurogastroenterology and Motility in September 2023. At the end of this summary, there are links to websites where you can find more information about this study. Tenapanor (IBSRELA®) is a newly available medicine in the United States. It is used to treat irritable bowel syndrome with constipation (IBS-C) in people aged 18 years and older. In 2 large clinical trials, tenapanor was shown to improve the symptoms of IBS-C. People with IBS-C often need to take long-term medicines to keep their symptoms under control. As a result, this study, called T3MPO-3 , was undertaken to investigate whether there are any possible side effects associated with the long-term use of tenapanor in adults with IBS-C. There were 312 people who had taken part in either of the original 2 trials and took part in this study, with 90 receiving tenapanor for at least 1 year. Loose or watery stool (diarrhea) was the most common side effect, and most cases were mild or moderate. No people died in any of these studies.

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/1756-2848Test

الوصول الحر: https://doaj.org/article/a42748ddee794bc48998e93ed4093048Test

المؤلفون: Steven F. Moss, William D. Chey, Patrick Daniele, Corey Pelletier, Rinu Jacob, Gabriel Tremblay, Elizabeth Hubscher, Eckhard Leifke, Peter Malfertheiner

المصدر: Therapeutic Advances in Gastroenterology, Vol 16 (2023)

مصطلحات موضوعية: Diseases of the digestive system. Gastroenterology, RC799-869

الوصف: Background: Helicobacter pylori eradication rates achieved with clarithromycin-based triple therapies are declining due to antibiotic resistance, but data regarding temporal changes in efficacy with these eradication therapies are scarce. Objective: To evaluate the efficacy of clarithromycin-based triple eradication regimens over time. Design: A comprehensive literature review and time-trend analysis. Data sources and methods: Bibliographies of recently published systematic literature reviews were searched and supplemented with a targeted literature review conducted using Medline and Embase databases and ProQuest from conception to May 2021. Studies reporting H. pylori eradication rates of clarithromycin-based triple therapies were included and temporal trends were estimated using a random-effects model. Results: Eradication rates for triple therapies containing proton pump inhibitors (PPIs), clarithromycin, and amoxicillin showed a significant decline over the past 23 years ( p = 0.0315). However, this decline was not significant when eradication rates achieved with vonoprazan-based triple therapy were included ( p = 0.3910). Conclusion: Vonoprazan-based triple therapy partially mitigated the decline in eradication rates seen with PPI-based triple therapy, likely due to more powerful acid suppression of vonoprazan.

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/1756-2848Test

الوصول الحر: https://doaj.org/article/ac1976321b6341f2b3feab136665bb2bTest

المؤلفون: Brian E. Lacy, William D. Chey, Michael S. Epstein, Syed M. Shah, Patrick Corsino, Linda R. Zeitzoff, Brooks D. Cash

المصدر: BMC Gastroenterology, Vol 22, Iss 1, Pp 1-9 (2022)

مصطلحات موضوعية: Abdominal pain, Caraway oil, Dyspepsia, Functional dyspepsia, L-menthol, Diseases of the digestive system. Gastroenterology, RC799-869

الوصف: Abstract Background A randomized, placebo-controlled clinical trial (FDREST) of a novel formulation of caraway oil and L-menthol (COLM-SST) demonstrated symptom relief in patients with functional dyspepsia (FD). Two follow-up studies were conducted to evaluate patient satisfaction, self-regulated dosing, and long-term safety data: FDACT, Functional Dyspepsia Adherence and Compliance Trial, and FDSU36, Functional Dyspepsia Safety Update at 36 months. Methods A patient reported outcomes (PRO) questionnaire was designed and distributed online to assess real-world satisfaction and dosing frequency of open-label COLM-SST in patients with FD. A separate study analyzing voluntary safety surveillance data evaluated the frequency and severity of reported adverse events (AEs). Results A total of 600 FD patients were enrolled in the PRO study. Ninety five percent of respondents reported a major or moderate improvement in their FD symptoms and 91.7% indicated a major or moderate improvement in quality of life (QOL) using COLM-SST. Between 1 and 4 capsules were consumed daily by 91.2% of respondents, with 56.2% taking them before meals. Symptom relief was rapid, with 86.4% of respondents indicating relief within 2 h of taking COLM-SST. Few adverse events (AEs) were reported (0.0187%) by patients using COLM-SST. No serious AEs were identified. Conclusion COLM-SST is safe, well tolerated, and provides rapid relief of FD symptoms. These findings, demonstrated in the FDREST trial, were further supported by a large prospective PRO study evaluating self-regulated dosing frequency, symptom improvement, and QOL. COLM-SST was well-tolerated based on review of AE data at 36 months.

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/1471-230XTest

الوصول الحر: https://doaj.org/article/24af56e881034192ac8cb1e8a7a1d9c1Test

المؤلفون: Peter Malfertheiner, Steven F. Moss, Patrick Daniele, Corey Pelletier, Rinu Jacob, Gabriel Tremblay, Elizabeth Hubscher, Eckhard Leifke, William D. Chey

المصدر: Gastro Hep Advances, Vol 1, Iss 5, Pp 824-834 (2022)

مصطلحات موضوعية: First-Line Regimens, Empiric Therapy, Network Meta-Analysis, Diseases of the digestive system. Gastroenterology, RC799-869

الوصف: Background and Aims: Effective acid suppression is a crucial component of Helicobacter pylori (H. pylori) eradication regimens. Approved treatments include dual, triple, and quadruple therapies composed of certain antibiotics in combination with proton pump inhibitors (PPIs). Vonoprazan, a potassium-competitive acid blocker, provides more potent and durable acid suppression than PPIs. We compared the efficacy of vonoprazan-based therapies vs approved standard regimens using new evidence from the phase 3 pHalconHP trial in North America and Europe. Methods: Studies reporting first-line H. pylori eradication rates from empiric treatment with Food and Drug Administration–approved therapies and vonoprazan-containing therapies were identified via bibliographic searches of systematic literature reviews and a subsequent MEDLINE/Embase search using index terms for H. pylori and eradication. Randomized controlled trials comparing 2 or more relevant comparators were included in Bayesian network meta-analyses for grouped and distinct therapies. Results: Twenty-three distinct regimens from 42 trials including 12,773 patients were identified. Vonoprazan-based triple therapy showed the highest relative efficacy (odds ratio: 2.73, 95% credible interval 2.11, 3.54) and 72.1% probability of being the best. North American, Western, and global scenarios were largely consistent. Vonoprazan-based therapies demonstrated higher odds of H. pylori eradication than each PPI-based triple therapy. Furthermore, vonoprazan-based triple therapy was superior to bismuth subcitrate quadruple therapy (odds ratio: 1.60, 95% credible interval: 1.07, 2.38). Conclusion: Vonoprazan-based eradication regimens represent novel treatments for H. pylori infection on a global scale, offering efficacy that, in this analysis, is superior to PPI-based triple therapy and comparable or better than bismuth quadruple therapy.

وصف الملف: electronic resource

العلاقة: http://www.sciencedirect.com/science/article/pii/S2772572322001042Test; https://doaj.org/toc/2772-5723Test

الوصول الحر: https://doaj.org/article/e981c329f8934408aa02764c741d38daTest

المؤلفون: Stacy B. Menees, Anthony J. Lembo, William D. Chey

المصدر: Canadian Journal of Gastroenterology and Hepatology, Vol 2022 (2022)

مصطلحات موضوعية: Diseases of the digestive system. Gastroenterology, RC799-869

الوصف: Background & Aims. The efficacy and safety of polyethylene glycol 3350 for chronic idiopathic constipation have been demonstrated in randomized controlled trials. A new US Food and Drug Administration-recommended primary efficacy endpoint for evaluating chronic idiopathic constipation prompted our reevaluation of previously reported clinical data with polyethylene glycol 3350. Methods. This multicenter, double-blind, placebo-controlled, parallel-group trial included adults with chronic idiopathic constipation randomized to polyethylene glycol 3350 17 g (n = 204) or placebo (n = 100) once daily for 24 weeks. Post hoc analyses were performed using the US Food and Drug Administration endpoint (≥3 complete spontaneous bowel movements/week and an increase of ≥1 complete spontaneous bowel movement/week from baseline for ≥9/12 weeks, including 3 of the last 4 weeks) along with additional efficacy and safety outcomes. Results. The proportion of patients meeting the new endpoint was significantly higher with polyethylene glycol 3350 vs placebo (42% vs 13%; P

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/2291-2797Test

الوصول الحر: https://doaj.org/article/4035290d48974db582f9bca60748466dTest

المؤلفون: Eric D. Shah, Jessica K. Salwen-Deremer, Peter R. Gibson, Jane G. Muir, Shanti Eswaran, William D. Chey

المصدر: MDM Policy & Practice, Vol 6 (2021)

مصطلحات موضوعية: Medicine (General), R5-920

الوصف: Introduction. Irritable bowel syndrome (IBS) is the most common gastroenterology referral and one of the most common gastrointestinal complaints in primary care. We performed a cost-utility analysis of the most common treatments available in general practice for IBS with constipation (IBS-C), the most expensive IBS subtype. Methods. We developed a decision analytic model evaluating guideline-recommended and Food and Drug Administration–approved drugs, supplements, and dietary/psychological interventions. Model inputs were derived from “global symptom improvement” outcomes in systematic reviews of clinical trials. Costs were derived from national datasets. Analysis was performed with a 1-year time horizon from patient and payer perspectives. We analyzed a prototypical managed-care health plan with no cost-sharing to the patient. Results. From a payer perspective, global IBS treatments (including low FODMAP, cognitive behavioral therapy [CBT], neuromodulators), which are not specific to the IBS-C bowel subtype were less expensive than on-label prescription drug treatments. From a patient perspective, on-label prescription drug treatment with linaclotide was the least expensive treatment strategy. Drug prices and costs to manage untreated IBS-C were most important determinants of payer treatment preferences. Effects of treatment on missed work-days and need for repeated appointments to complete treatment were the most important determinants of treatment preference to patients. Discussion. Due mostly to prescription drug prices, neuromodulators, low FODMAP, and CBT appear cost-effective compared to on-label drug treatments from a payer perspective in cost-utility analysis. These findings may explain common treatment barriers in clinical practice.

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/2381-4683Test

الوصول الحر: https://doaj.org/article/19ce2652df2248529a024af096a5cf59Test

المؤلفون: M. A. Azcarate-Peril, J. Roach, A. Marsh, William D. Chey, William J. Sandborn, Andrew J. Ritter, Dennis A. Savaiano, T. R. Klaenhammer

المصدر: Gut Microbes, Vol 13, Iss 1 (2021)

مصطلحات موضوعية: prebiotics, microbiome modulation, lactose intolerance, human lactase, bifidobacterium, short chain fatty acids, galacto-oligosaccharides, gos, Diseases of the digestive system. Gastroenterology, RC799-869

الوصف: Background. Our recent publication (Chey et al., Nutrients 2020) showed that a 30-day administration of pure galacto-oligosaccharides (GOS) significantly reduced symptoms and altered the fecal microbiome in patients with lactose intolerance (LI). Results. In this addendum, we performed an in-depth analysis of the fecal microbiome of the 377 LI patients randomized to one of two GOS doses (Low, 10–15 grams/day or High, 15–20 grams/day), or placebo in a multi-center, double-blinded, placebo-controlled trial. Sequencing of 16S rRNA amplicons was done on GOS or placebo groups at weeks zero (baseline), four (end of treatment), nine, 16 and 22. Taxa impacted by treatment and subsequent dairy consumption included lactose-fermenting species of Bifidobacterium, Lactobacillus, Lactococcus, and Streptococcus. Increased secondary fermentation microorganisms included Coprococcus and Ruminococcus species, Blautia producta, and Methanobrevibacterium. Finally, tertiary fermenters that use acetate to generate butyrate were also increased, including Faecalibacterium prausnitzii, Roseburia faecis, and C. eutactus. Conclusions. Results confirmed and expanded data on GOS microbiome modulation in LI individuals. Microbiome analysis at 16 and 22 weeks after treatment further suggested relatively long-term benefits when individuals continued consumption of dairy products.

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/1949-0976Test; https://doaj.org/toc/1949-0984Test

الوصول الحر: https://doaj.org/article/d47410bb244542d6bd8c000d5533fe53Test

المؤلفون: Ali Attari, William D. Chey, Jason R. Baker, James A. Ashton-Miller, Peter F. W. M. Rosier

المصدر: PLoS ONE, Vol 15, Iss 9 (2020)

مصطلحات موضوعية: Medicine, Science

الوصف: There is a need for a lower cost manometry system for assessing anorectal function in primary and secondary care settings. We developed an index finger-based system (termed “digital manometry”) and tested it in healthy volunteers, patients with chronic constipation, and fecal incontinence. Anorectal pressures were measured in 16 participants with the digital manometry system and a 23-channel high-resolution anorectal manometry system. The results were compared using a Bland-Altman analysis at rest as well as during maximum squeeze and simulated defecation maneuvers. Myoelectric activity of the puborectalis muscle was also quantified simultaneously using the digital manometry system. The limits of agreement between the two methods were -7.1 ± 25.7 mmHg for anal sphincter resting pressure, 0.4 ± 23.0 mmHg for the anal sphincter pressure change during simulated defecation, -37.6 ± 50.9 mmHg for rectal pressure changes during simulated defecation, and -20.6 ± 172.6 mmHg for anal sphincter pressure during the maximum squeeze maneuver. The change in the puborectalis myoelectric activity was proportional to the anal sphincter pressure increment during a maximum squeeze maneuver (slope = 0.6, R2 = 0.4). Digital manometry provided a similar evaluation of anorectal pressures and puborectalis myoelectric activity at an order of magnitude less cost than high-resolution manometry, and with a similar level of patient comfort. Digital Manometry provides a simple, inexpensive, point of service means of assessing anorectal function in patients with chronic constipation and fecal incontinence.

وصف الملف: electronic resource

العلاقة: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7523952/?tool=EBITest; https://doaj.org/toc/1932-6203Test

الوصول الحر: https://doaj.org/article/fba80ea0bb5847f381d35f42671e76d3Test

المؤلفون: William D. Chey, Eric D. Shah, Herbert L. DuPont

المصدر: Therapeutic Advances in Gastroenterology, Vol 13 (2020)

مصطلحات موضوعية: Diseases of the digestive system. Gastroenterology, RC799-869

الوصف: Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder with a multifactorial pathophysiology. The gut microbiota differs between patients with IBS and healthy individuals. After a bout of acute gastroenteritis, postinfection IBS may result in up to approximately 10% of those affected. Small intestinal bacterial overgrowth (SIBO) is more common in patients with IBS than in healthy individuals, and eradication of SIBO with systemic antibiotics has decreased symptoms of IBS in some patients with IBS and SIBO. The nonsystemic (i.e. low oral bioavailability) antibiotic rifaximin is indicated in the United States and Canada for the treatment of adults with IBS with diarrhea (IBS-D). The efficacy and safety of 2-week single and repeat courses of rifaximin have been demonstrated in randomized, placebo-controlled studies of adults with IBS. Rifaximin is widely thought to exert its beneficial clinical effects in IBS-D through manipulation of the gut microbiota. However, current studies indicate that rifaximin induces only modest effects on the gut microbiota of patients with IBS-D, suggesting that the efficacy of rifaximin may involve other mechanisms. Indeed, preclinical data reveal a potential role for rifaximin in the modulation of inflammatory cytokines and intestinal permeability, but these two findings have not yet been examined in the context of clinical studies. The mechanism of action of rifaximin in IBS is likely multifactorial, and further study is needed.

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/1756-2848Test

الوصول الحر: https://doaj.org/article/0fb107828bab416eab9b1c76424c7480Test