Therapeutic Advances in Gastroenterology最新文献

{"title":"The effect of synbiotics in patients with NAFLD: a systematic review and meta-analysis.","authors":"Jiacheng Cai,&nbsp;Jia Dong,&nbsp;Dahua Chen,&nbsp;Hua Ye","doi":"10.1177/17562848231174299","DOIUrl":"https://doi.org/10.1177/17562848231174299","url":null,"abstract":"<p><strong>Background: </strong>Nonalcoholic fatty liver disease (NAFLD) is the highest incidence of chronic liver disease worldwide, seriously endangering human health, and its pathogenesis is still unclear. In the recent years, increasing evidence has shown that intestinal flora plays an important role in the occurrence and development of NAFLD. Synbiotics can alter gut microbiota and may be a treatment option for NAFLD in the future.</p><p><strong>Objectives: </strong>To systematically investigate the therapeutic effect of synbiotic supplementation on NAFLD patients.</p><p><strong>Design: </strong>A systematic review and meta-analysis were conducted.</p><p><strong>Data sources and methods: </strong>We conducted a search on four databases (PubMed, Embase, Cochrane Library, and Web of Science) to identify relevant studies. Eligible studies were then screened, and data from the included studies were extracted, combined, and analyzed.</p><p><strong>Result: </strong>This study analyzed 10 randomized controlled trials involving 634 patients with NAFLD. The results showed that synbiotic supplementation could significantly reduce the level of alanine aminotransferase (mean difference (MD) = -8.80; (95% CI [-13.06, -4.53]), <i>p</i> < 0.0001), aspartate aminotransferase (MD = -9.48; 95% CI [-12.54, -6.43], <i>p</i> < 0.0001), and γ-glutamyl transferase (MD = -12.55; 95% CI [-19.40, -5.69], <i>p</i> = 0.0003) in NAFLD patients. In the field of metabolism, synbiotic supplementation could significantly reduce the level of total cholesterol (MD = -11.93; 95% CI [-20.43, -3.42], <i>p</i> = 0.006) and low-density lipoprotein cholesterol (MD = -16.2; 95% CI [-19.79, -12.60], <i>p</i> < 0.0001) and increase the level of high-density lipoprotein cholesterol (MD = 1.56; 95% CI [0.43, 2.68], <i>p</i> = 0.007) in NAFLD patients. In addition, synbiotic supplementation could significantly reduce liver stiffness measurement indicator (MD = -1.09; 95% CI [-1.87, -0.30], <i>p</i> = 0.006) and controlled attenuation parameter indicator (MD = -37.04; 95% CI [-56.78, -17.30], <i>p</i> = 0.0002) in NAFLD patients.</p><p><strong>Conclusion: </strong>Based on the current evidence, synbiotic supplementation can improve liver function, adjust lipid metabolism, and reduce the degree of liver fibrosis in patients with NAFLD, but these effects need to be confirmed by further studies.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231174299"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1b/5b/10.1177_17562848231174299.PMC10302525.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10303389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of early aggressive versus nonaggressive fluid resuscitation in acute pancreatitis: a meta-analysis.","authors":"Jian Guo,&nbsp;Jiaze Hong,&nbsp;Yujing He,&nbsp;Qingyuan Li,&nbsp;Tongmin Huang,&nbsp;Dandi Lou,&nbsp;Jie Zhang","doi":"10.1177/17562848231192144","DOIUrl":"https://doi.org/10.1177/17562848231192144","url":null,"abstract":"<p><strong>Background: </strong>Early fluid resuscitation is one of the main therapeutic strategies for acute pancreatitis (AP). This study investigated the effects of early aggressive and nonaggressive hydration on AP.</p><p><strong>Objectives: </strong>The aim of this meta-analysis is to investigate the differences between aggressive and nonaggressive intravenous fluid resuscitation in AP.</p><p><strong>Design: </strong>This study was based on publicly available data, all of which have been extracted from previous ethically approved studies.</p><p><strong>Data sources and methods: </strong>Two authors systematically searched PubMed, Embase (via OVID), Web of Science, and Cochrane Library to find all published research before February 2023. In-hospital mortality were set as primary endpoints.</p><p><strong>Results: </strong>This meta-analysis included seven randomized controlled trials (RCTs) and eight cohort studies with 4072 individuals in nonaggressive (<i>n</i> = 2419) and aggressive (<i>n</i> = 1653) hydration groups. The results showed that patients in the nonaggressive group had a lower mortality rate than those in the aggressive hydration group [relative risks (RR), 0.66; <i>p</i> = 0.02]. Subgroup analysis results showed that patients in the nonaggressive hydration group had lower mortality rates in RCTs (RR, 0.39; <i>p</i> = 0.001), studies conducted in Eastern countries (RR, 0.63; <i>p</i> = 0.002), and studies with severe pancreatitis (RR, 0.65; <i>p</i> = 0.02). In addition, the nonaggressive hydration group had lower rates of infection (RR, 0.62; <i>p</i> < 0.001), organ failure (RR, 0.65; <i>p</i> = 0.02), and shock (RR, 0.21; <i>p</i> = 0.02), as well as a shorter hospital stay (weighted mean difference, -1.63; <i>p</i> = 0.001) than the aggressive hydration group.</p><p><strong>Conclusions: </strong>Early nonaggressive fluid resuscitation is associated with lower mortality, lower risk of organ failure and infection, and shorter hospital stays than aggressive fluid resuscitation.</p><p><strong>Registration prospero registration number: </strong>CRD42023396388.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231192144"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f2/d2/10.1177_17562848231192144.PMC10467253.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10308083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 vaccination in adults with inflammatory bowel disease.","authors":"Megan Lutz,&nbsp;Sarah Lazarus,&nbsp;Freddy Caldera","doi":"10.1177/17562848231173130","DOIUrl":"https://doi.org/10.1177/17562848231173130","url":null,"abstract":"<p><p>Patients with inflammatory bowel disease (IBD) are not at increased risk of SARS-CoV-2 infection compared to the general population, and most are not at increased risk for severe disease. COVID-19 is nonetheless common, and vaccination is critical. Four safe and efficacious vaccines are now available for the prevention of COVID-19, with most data available for mRNA vaccines. Patients with IBD have a robust humoral response to vaccination with rates of seroconversion exceeding 95% following a two-dose mRNA vaccine series and 99% following a three-dose mRNA series, although those on certain therapies including anti-tumor necrosis factor α agents may have lower antibody concentrations and waning of antibodies over time. Additionally, rates of cell-mediated immune response, even in those patients with IBD who did not have evidence of humoral immunity, are high. Vaccines are safe and have not been associated with flares in disease activity. Gastroenterology providers should take an active role in ensuring patients with IBD are appropriately vaccinated against COVID-19.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231173130"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d7/b5/10.1177_17562848231173130.PMC10203854.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9528838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is there an optimal sequence of biologic therapies for inflammatory bowel disease?","authors":"Brian Bressler","doi":"10.1177/17562848231159452","DOIUrl":"https://doi.org/10.1177/17562848231159452","url":null,"abstract":"<p><p>Over the past two decades, 11 biologic agents have been approved for use in most countries for the treatment of moderate-to-severe inflammatory bowel disease (IBD). Antitumor necrosis factor α (anti-TNF) agents are commonly used as the first biologic in clinical practice, and nearly all pivotal studies of induction therapy enrolled patients with and without prior use of anti-TNF therapy. This narrative review presents a reasonable approach to devising treatment sequences, examining the magnitude of benefit for each drug <i>versus</i> placebo or active comparator and then considering how that benefit changes with prior anti-TNF treatment. Data from ULTRA 2, GEMINI 1, VARSITY, and True North in patients with ulcerative colitis indicate that induction adalimumab, vedolizumab, and ozanimod showed lower clinical remission rates after anti-TNF therapy, while UNIFI, OCTAVE 1&2, and U-ACHIEVE/U-ACCOMPLISH show ustekinumab, tofacitinib, and upadacitinib did not. In patients with Crohn's disease, endoscopic remission or mucosal healing after induction therapy rather than clinical remission as well as assessment of persistent endoscopic remission are good measures of long-term disease outcomes. Considering the drugs for which data on endoscopic remission rates are available, EXTEND and GEMINI 2&3 show adalimumab and vedolizumab with persistently lower endoscopic remission rates after prior anti-TNF therapy, while IM-UNIFI, SEAVUE, and FORTIFY show ustekinumab and risankizumab did not. Data from the multicenter retrospective EVOLVE study indicate that the effectiveness of anti-TNF therapy does not seem to be significantly impacted by prior vedolizumab therapy, and may further suggest the benefit of using vedolizumab as a first-line biologic. As adverse event rates remain low across all treatments, the magnitude of harm from untreated or poorly treated disease far outweighs harm from any individual therapy. Regardless of the treatment sequence, careful monitoring for early signs of treatment nonresponse and switching to another potentially highly active therapy are critical to effective management of IBD.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231159452"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10087655/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9674905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PERFUSE: a French non-interventional study of patients with inflammatory bowel disease receiving infliximab biosimilar SB2: a 12-month analysis.","authors":"Yoram Bouhnik,&nbsp;Bruno Fautrel,&nbsp;Laurent Beaugerie,&nbsp;Anne-Laure Pelletier,&nbsp;Christine Martinez-Vinson,&nbsp;Ulrich Freudensprung,&nbsp;Amira Brigui,&nbsp;Janet Addison","doi":"10.1177/17562848221145654","DOIUrl":"https://doi.org/10.1177/17562848221145654","url":null,"abstract":"<p><strong>Background: </strong>Flixabi^TM (SB2) is a biosimilar of the reference infliximab (IFX), Remicade^®. Published evidence on long-term, real-world use of SB2 in patients either IFX naive or transitioned from prior IFX is scarce.</p><p><strong>Objectives: </strong>We evaluated persistence, effectiveness, and safety of SB2 over 12 months in adults with IBD [Crohn's disease (CD) and ulcerative colitis (UC)], participating in PERFUSE.</p><p><strong>Design: </strong>PERFUSE is a long-term, non-interventional, multicenter study of patients receiving SB2 at specialist sites across France.</p><p><strong>Methods: </strong>SB2 treatment was initiated in September 2017, either as first IFX treatment (IFX naive), after transition from treatment with reference IFX (IFX ref) or another IFX biosimilar (IFX bs), or both IFX ref and IFX bs (IFX multiswitch). Outcomes up to Month 12 (±2) include persistence on SB2 (primary outcome measure), SB2 dose, disease status, immunogenicity, and safety.</p><p><strong>Results: </strong>This final 12-month analysis of patients with IBD includes 569 with CD and 168 with UC. Persistence [95% confidence interval (CI)] at Month 12 was CD: 89% (77.2; 94.9), UC: 78.5% (58.2; 89.8) for IFX naive; CD: 94% (91.0; 96.1), UC: 92.8% (84.8; 96.7) for IFX ref; CD: 91.6% (86.0; 95.0), UC: 94.2% (83.1; 98.1) for IFX bs; and CD 100% (100; 100), UC 100% (100; 100) for IFX multiswitch. In the CD and UC cohorts, disease activity among IFX naive patients declined from baseline to Month 12; with any prior IFX, the proportions of patients in remission at baseline, Month 6, and Month 12 remained unchanged in the UC cohort, and were comparable or higher in the CD cohort. No immunogenicity or safety signals were detected.</p><p><strong>Conclusions: </strong>Patients with IBD can be initiated on SB2 or transitioned from IFX ref and/or IFX bs to SB2, with no loss of disease control or safety concerns, with >75% of naive and >90% of transitioned patients continuing on SB2 treatment at 12 months.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848221145654"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c7/9a/10.1177_17562848221145654.PMC10021102.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9146399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of imaging modalities for decision-making in inflammatory bowel disease.","authors":"Stéphane Nancey,&nbsp;Mathurin Fumery,&nbsp;Mathias Faure,&nbsp;Gilles Boschetti,&nbsp;Claire Gay,&nbsp;Laurent Milot,&nbsp;Xavier Roblin","doi":"10.1177/17562848231151293","DOIUrl":"https://doi.org/10.1177/17562848231151293","url":null,"abstract":"Cross-sectional magnetic resonance enterography (MRE) and intestinal ultrasonography (IUS) provide valuable and noninvasive information to accurately assess disease activity, severity, and extent; detect complications; and monitor the response to treatment, as well as predict the postoperative recurrence of Crohn’s disease and a negative disease course. Therefore, both imaging modalities are emerging as pivotal diagnostic tools to achieve the emerging therapeutic target of transmural healing associated with better disease outcomes. Despite its numerous potential advantages over endoscopy and even MRE and its good availability, IUS is still widely underused to monitor and manage inflammatory bowel disease (IBD) patients and help in making clinical decisions in routine practice. This situation is clearly due to the absence of validated, reliable, and responsive indices, as well as the lack of trained gastroenterologists and radiologists, as IUS is a component of radiologist expertise in several countries but not yet integrated into the training program of gastroenterologists. However, there is an increasing body of evidence in the literature that IUS and MRE are both becoming essential imaging resources to help clinicians in making reliable decisions. Here, we discuss the up-to-date evidence about the usefulness and performance of cross-sectional imaging, focusing on the ability of bowel US and MRE to aid clinical decision-making for the optimal management and monitoring of IBD.","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231151293"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c8/bc/10.1177_17562848231151293.PMC9912556.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10765243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of starch- and sucrose-reduced diet accompanied by nutritional and culinary recommendations on the symptoms of irritable bowel syndrome patients with diarrhoea.","authors":"Lucia Gayoso,&nbsp;Koldo Garcia-Etxebarria,&nbsp;Teresa Arzallus,&nbsp;Isabel Montalvo,&nbsp;Jacobo Lizasoain,&nbsp;Mauro D'Amato,&nbsp;Usune Etxeberria,&nbsp;Luis Bujanda","doi":"10.1177/17562848231156682","DOIUrl":"https://doi.org/10.1177/17562848231156682","url":null,"abstract":"<p><strong>Background: </strong>Irritable bowel syndrome (IBS) is a common gastrointestinal condition which entails a high burden in the quality of life (QoL) of patients. Nutritional interventions have been proposed to alleviate symptoms, since still no effective treatments exist for IBS.</p><p><strong>Objectives: </strong>Our aim is to analyse the feasibility of the use of starch- and sucrose-reduced diet (SSRD).</p><p><strong>Design: </strong>In this study, we used a SSRD accompanied by nutritional and culinary recommendations to measure the effects in IBS patients with diarrhoea.</p><p><strong>Methods: </strong>In all, 34 participants completed a 4-week nutritional intervention based on SSRD. Symptoms, QoL and dietary habits were assessed by several questionnaires that were completed at the beginning, daily, after 2 weeks, at the end, and after 2 months.</p><p><strong>Results: </strong>85.29% of the participants reached the primary endpoint [reduction of 50 points or more in IBS-symptom severity scale (SSS)], and 58.82% the secondary endpoint (reduction of 50% or more in IBS-SSS). The relief of symptoms and improvement of the QoL were significant after 2 weeks of intervention, at the end and after 2 months. Dietary habits were consistent with the diet and high adherence was achieved.</p><p><strong>Conclusions: </strong>SSRD and individualized nutritional and culinary guidance improved symptoms and QoL of IBS patients with diarrhoea, with a high adherence.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231156682"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/77/e2/10.1177_17562848231156682.PMC10155021.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10296437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gastrointestinal injury induced by immunomodulators: A review article.","authors":"Pingxin Zhang,&nbsp;Ren Mao,&nbsp;Chuhan Zhang,&nbsp;Yun Qiu,&nbsp;Minhu Chen","doi":"10.1177/17562848231158549","DOIUrl":"https://doi.org/10.1177/17562848231158549","url":null,"abstract":"<p><p>An increasing number of immunomodulators, either anti-inflammatory or immunity-enhancing, have brought about a revolutionary effect in the management of a variety of autoimmune disorders and malignancies. However, their ability to cause gastrointestinal (GI) injury and induce GI symptoms has been increasingly and unexpectedly recognized. GI injury associated with immunomodulators may demonstrate various histologic and endoscopic patterns. Optimal diagnosis and treatment require a multidisciplinary approach. This review aims to provide an overview of the literature on its pathogenesis, the clinical, endoscopic, and histologic features, and suggested approaches to manage these newly recognized immunomodulator-induced GI adverse effects (AEs). We also reviewed current biomarkers predictive of GI toxicity and potential risk factors to identify susceptible patients. In addition, these immune-mediated AEs were compared with inflammatory bowel disease, a well-documented form of inflammation-driven GI injury. We hope this review will raise awareness and vigilance among clinicians of these entities to increase early diagnosis and rapid referral to specialist care.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231158549"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a7/50/10.1177_17562848231158549.PMC10126616.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9733152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rights and wrongs of <i>Helicobacter pylori</i> testing and treatment in children.","authors":"Toshihiko Kakiuchi","doi":"10.1177/17562848231195251","DOIUrl":"https://doi.org/10.1177/17562848231195251","url":null,"abstract":"Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the Sage and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). TherapeuTic advances in Gastroenterology","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231195251"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/74/bd/10.1177_17562848231195251.PMC10467163.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10134694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of fecal microbiota, live-jslm (REBYOTA^™) in individuals with recurrent <i>Clostridioides difficile</i> infection: data from five prospective clinical trials.","authors":"Christine Lee,&nbsp;Thomas Louie,&nbsp;Lindy Bancke,&nbsp;Beth Guthmueller,&nbsp;Adam Harvey,&nbsp;Paul Feuerstadt,&nbsp;Sahil Khanna,&nbsp;Robert Orenstein,&nbsp;Erik R Dubberke","doi":"10.1177/17562848231174277","DOIUrl":"https://doi.org/10.1177/17562848231174277","url":null,"abstract":"<p><strong>Background: </strong>Microbiota-based treatments reduce the incidence of recurrent <i>Clostridioides difficile</i> infections (rCDIs), but prospectively collected safety data needed to broaden patient access and protect public health have been limited.</p><p><strong>Objectives: </strong>We provide cumulative safety data from five prospective clinical trials evaluating fecal microbiota, live-jslm (RBL) - the first microbiota-based live biotherapeutic product approved by the US Food and Drug Administration - for preventing rCDI in adults.</p><p><strong>Design: </strong>Integrated safety analysis includes three phase II trials (PUNCH CD, PUNCH CD2, PUNCH Open-Label) and two phase III trials (PUNCH CD3, PUNCH CD3-OLS) of RBL.</p><p><strong>Methods: </strong>Trial participants were at least 18 years of age with documented rCDI who completed standard-of-care antibiotic therapy before treatment with RBL. Assigned study treatment regimen was one or two doses of RBL (or placebo) administered rectally, depending on the trial design. In four of the five trials, participants with CDI recurrence within 8 weeks after RBL or placebo administration were eligible for treatment with open-label RBL. Treatment-emergent adverse events (TEAEs) were recorded for at least 6 months following last study treatment; in PUNCH CD2 and PUNCH Open-Label trials, TEAEs and serious TEAEs were collected through 12 and 24 months, respectively.</p><p><strong>Results: </strong>Among the five trials, 978 participants received at least one dose of RBL (assigned treatment or after recurrence) and 83 participants received placebo only. TEAEs were reported in 60.2% of Placebo Only participants and 66.4% of RBL Only participants. Only abdominal pain, nausea, and flatulence were significantly higher in the RBL Only group compared with the Placebo Only group. Most TEAEs were mild or moderate in severity and were most frequently related to preexisting conditions. There were no reported infections for which the causative pathogen was traced to RBL. Potentially life-threatening TEAEs were infrequent (3.0% of participants).</p><p><strong>Conclusion: </strong>Across five clinical trials, RBL was well tolerated in adults with rCDI. In aggregate, these data consistently demonstrated the safety of RBL.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231174277"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/80/0d/10.1177_17562848231174277.PMC10272687.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10302169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}