Therapeutic Advances in Gastroenterology最新文献

{"title":"Effects of Crohn's disease exclusion diet on remission: a systematic review.","authors":"Zhanhui Zhu, Yang Lei, Zheng Lin","doi":"10.1177/17562848231184056","DOIUrl":"10.1177/17562848231184056","url":null,"abstract":"<p><strong>Background: </strong>Dietary therapy may potentially reduce inflammation and promote mucosal healing in patients with Crohn's disease and is associated with fewer side effects and lower cost compared to medical therapy. Recently the Crohn's disease exclusion diet (CDED) has been developed to reduce exposure to individualized dietary components which negatively affect the intestine in patients with Crohn's disease.</p><p><strong>Objectives: </strong>This systematic review aimed to explore the effectiveness of CDED in Crohn's disease patients.</p><p><strong>Design: </strong>A systematic review.</p><p><strong>Data sources and methods: </strong>A systematic search was performed on the PubMed, EBSCOhost, Cochrane library, OVID, Embase, Scopus, and CINHAL to identify relevant clinical trials published from 1 January 2014 to 31 August 2022.</p><p><strong>Results: </strong>A total of 1120 studies were identified and 7 studies were finally included in the analysis. The study was reported according to Preferred Reporting Items for Systematic Reviews and Meta-analysis statement.</p><p><strong>Conclusion: </strong>Our findings suggested that the use of CDED seemed to be effective for induction and maintenance of remission in children and adults with mild to moderate Crohn's disease. However, heterogeneity and limitations existed among the studies included. Further investigation in the form of well-designed randomized clinical trials is needed to validate the present findings.</p><p><strong>Registration: </strong>PROSPERO registration number CRD42022335453.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231184056"},"PeriodicalIF":4.2,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a5/db/10.1177_17562848231184056.PMC10467299.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10136727","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":"Intravenous ustekinumab maintenance treatment in patients with loss of response to subcutaneous dosing.","authors":"Federico Argüelles-Arias, Teresa Valdés Delgado, Belén Maldonado Pérez, Jaime González Antuña, Luisa Castro Laria","doi":"10.1177/17562848231191670","DOIUrl":"10.1177/17562848231191670","url":null,"abstract":"<p><strong>Background: </strong>Ustekinumab (UST) is indicated for the treatment of Crohn's disease (CD) and Ulcerative Colitis (UC). Despite having shown clinical effectiveness in the real world, some patients may lose response over time or need a higher dose to achieve it. In this context, UST intravenous (IV) maintenance has been proposed.</p><p><strong>Objectives: </strong>The primary endpoint of our study was to evaluate the efficacy and safety of maintenance IV UST treatment in Inflammatory Bowel Disease (IBD) patients who present with partial response or loss of response to subcutaneous (SC) UST.</p><p><strong>Design: </strong>We performed a monocentric observational retrospective study including patients with active IBD on maintenance treatment with IV UST.</p><p><strong>Methods: </strong>The clinical response and remission was analyzed at week 12, defined as either Harvey-Bradshaw Index ⩽ 4 for CD or partial Mayo Score ⩽ 2 for UC. The reduction of objective markers of disease activity, fecal calprotectin, and C-reactive protein was evaluated. Moreover, UST trough levels were measured pre- and post-UST IV maintenance and any adverse events were assessed.</p><p><strong>Results: </strong>We included 23 patients. Clinical remission at week 12 was achieved by 43.5% of the patients. The proportion of patients in clinical response after 12 weeks on UST IV maintenance was 82.6%. After a median follow-up of 9.3 months all patients remained on IV UST maintenance. No adverse events were recorded in any patient for the duration of the study.</p><p><strong>Conclusions: </strong>IV UST maintenance treatment was able to recapture response in most of the patients who had lost response to SC maintenance.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231191670"},"PeriodicalIF":3.4,"publicationDate":"2023-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ca/d7/10.1177_17562848231191670.PMC10467174.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10134696","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 in patients with liver disease and liver transplant: clinical implications, prevention, and management.","authors":"Gabriel Perreault, Charlotte Ching, Yael R Nobel","doi":"10.1177/17562848231188586","DOIUrl":"10.1177/17562848231188586","url":null,"abstract":"<p><p>The coronavirus disease 2019 (COVID-19) pandemic has had enormous implications for the care of patients with chronic liver disease (CLD), cirrhosis, and liver transplant (LT). Clinical outcomes of COVID-19 vary in patients with CLD and cirrhosis compared to healthy controls, and in patients with LT compared to patients without LT. Several special considerations apply to the approach to vaccination and treatment in patients with CLD and LT. The practice of liver transplantation has also been heavily impacted by the pandemic, including persistent reductions in living donor LT and increases in LT for an indication of alcohol-related liver disease. Recent medical society guidelines strive to standardize severe acute respiratory syndrome coronavirus 2 testing in donors and recipients and the approach to transplantation after recovered from COVID-19 infection, but certain controversies remain.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231188586"},"PeriodicalIF":3.4,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fe/e9/10.1177_17562848231188586.PMC10372508.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9912597","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":"SARS-CoV-2 breakthrough infections after COVID-19 vaccination in patients with inflammatory bowel disease: a systematic review and meta-analysis.","authors":"Natasja van de Pol, Qiuwei Pan, Lauranne A A P Derikx, Linda Bakker, C Janneke van der Woude, Annemarie C de Vries","doi":"10.1177/17562848231174295","DOIUrl":"10.1177/17562848231174295","url":null,"abstract":"<p><strong>Background: </strong>Patients with inflammatory bowel disease (IBD) have an attenuated serologic response to COVID-19 vaccination. It is unclear whether an impaired immune response in vaccinated IBD patients impacts the susceptibility to SARS-CoV-2 infection and occurrence of severe COVID-19.</p><p><strong>Objectives: </strong>To evaluate SARS-CoV-2 breakthrough infection rates and the disease course of COVID-19 in vaccinated IBD patients.</p><p><strong>Design: </strong>A systematic literature search and meta-analysis was performed.</p><p><strong>Data sources and methods: </strong>The search was performed in Embase, Medline, Web of Science Core Collection, Cochrane Central Register of Controlled Trials and CINAHIL. The articles were independently screened and selected by two reviewers. A random-effects model was used to calculate the pooled relative risk for breakthrough infections in vaccinated IBD patients and controls.</p><p><strong>Results: </strong>A total of 16 studies were included, with study periods ranging from January 2020 to October 2021 and follow-up time from 3 weeks to 6 months. The breakthrough infection rates range from 0 to 37.4% in vaccinated IBD patients. The disease course of COVID-19 was generally mild, with low hospitalization and mortality rates (0-8.7% and 0-4.3%, respectively). Vaccinated IBD patients had a significantly lower relative risk of breakthrough infection rate compared to unvaccinated controls (risk ratio: 0.07, 95% CI: 0.03-0.18). No difference was observed between IBD patients and non-IBD controls, and between partially and fully vaccinated IBD patients. The impact of immunosuppressive therapy on breakthrough infection rates differs between studies. Most studies showed no impact from immunosuppressive treatment, anti-tumour necrosis factor alpha or corticosteroids and other biologics; one study reported higher rates for patients treated with infliximab <i>versus</i> vedolizumab.</p><p><strong>Conclusion: </strong>Vaccination is effective to prevent COVID-19 infections in patients with IBD. Breakthrough infections do occur, but the disease course is generally mild. Available data seem to suggest a declining trend of breakthrough infections during calendar time.</p><p><strong>Registration: </strong>The protocol was published in the PROSPERO database (CRD42021292853).</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231174295"},"PeriodicalIF":3.4,"publicationDate":"2023-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bf/38/10.1177_17562848231174295.PMC10350577.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9831672","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":"Challenges in the diagnosis and management of IBD: a sub-Saharan African perspective.","authors":"Gill Watermeyer, Leolin Katsidzira, Bright Nsokolo, Olusegun Isaac Alatise, Babatunde M Duduyemi, Chris Kassianides, Phoebe Hodges","doi":"10.1177/17562848231184986","DOIUrl":"10.1177/17562848231184986","url":null,"abstract":"<p><p>With the exception of South Africa, inflammatory bowel disease (IBD) has long been considered uncommon in sub-Saharan Africa (SSA) with a dearth of peer-reviewed publications from the subcontinent. This most likely reflects underreporting as some cases may be missed due to the high burden of infectious diseases which may closely mimic IBD. In addition, many countries in SSA have limited endoscopic capacity, inadequate access to diagnostic imaging and a notable scarcity of histopathologists, radiologists and gastroenterologists. Beyond these obstacles, which significantly impact patient care, there are many other challenges in SSA, particularly the unavailability of key IBD therapies. In this review, we discuss barriers in diagnosing and managing IBD in SSA, as well as some of the initiatives currently in place to address these short comings.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231184986"},"PeriodicalIF":3.4,"publicationDate":"2023-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10345935/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9816630","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":"Brief communication: global temporal trends in the efficacy of clarithromycin-based regimens for the treatment of <i>Helicobacter pylori</i> infection.","authors":"Steven F Moss, William D Chey, Patrick Daniele, Corey Pelletier, Rinu Jacob, Gabriel Tremblay, Elizabeth Hubscher, Eckhard Leifke, Peter Malfertheiner","doi":"10.1177/17562848231167284","DOIUrl":"10.1177/17562848231167284","url":null,"abstract":"<p><strong>Background: </strong><i>Helicobacter pylori</i> 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.</p><p><strong>Objective: </strong>To evaluate the efficacy of clarithromycin-based triple eradication regimens over time.</p><p><strong>Design: </strong>A comprehensive literature review and time-trend analysis.</p><p><strong>Data sources and methods: </strong>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 <i>H. pylori</i> eradication rates of clarithromycin-based triple therapies were included and temporal trends were estimated using a random-effects model.</p><p><strong>Results: </strong>Eradication rates for triple therapies containing proton pump inhibitors (PPIs), clarithromycin, and amoxicillin showed a significant decline over the past 23 years (<i>p</i> = 0.0315). However, this decline was not significant when eradication rates achieved with vonoprazan-based triple therapy were included (<i>p</i> = 0.3910).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231167284"},"PeriodicalIF":4.2,"publicationDate":"2023-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4f/18/10.1177_17562848231167284.PMC10302680.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10303391","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":"Because I'm happy - positive affect and its predictive value for future disease activity in patients with inflammatory bowel diseases: a retrospective cohort study.","authors":"Brian M Lang, Martina Ledergerber, Sebastian Bruno Ulrich Jordi, Niklas Krupka, Luc Biedermann, Philipp Schreiner, Pascal Juillerat, Jacqueline Wyss, Stephan R Vavricka, Jonas Zeitz, Roland von Känel, Gerhard Rogler, Niko Beerenwinkel, Benjamin Misselwitz","doi":"10.1177/17562848231179335","DOIUrl":"10.1177/17562848231179335","url":null,"abstract":"<p><strong>Background: </strong>While the detrimental impact of negative emotions on the clinical course of inflammatory bowel disease (IBD) and quality of life has been extensively investigated, evidence for a potential impact of positive emotions is scarce.</p><p><strong>Objectives: </strong>We aim to analyse contributing factors of positive affect and their predictive value for disease course in IBD patients.</p><p><strong>Design: </strong>In this retrospective cohort study, epidemiological, psychosocial and IBD disease characteristics of Swiss IBD cohort study patients were analysed longitudinally.</p><p><strong>Methods: </strong>Epidemiological, psychosocial and disease characteristics were extracted from the database of the Swiss IBD cohort study. Participants' positive emotions were assessed cross-sectionally with the seven-item Marburg questionnaire (range 1-6) addressing positive affect in different aspects of daily life. Predictors of positive emotions were identified by linear regression. The quantitative longitudinal impact of positive emotions on the further disease course was analysed using a multivariable Cox proportional hazards model.</p><p><strong>Results: </strong>Among 702 IBD patients, those reporting more positive emotions were found to have significantly less intense medical treatment, less pain and fewer depressive symptoms (<i>p</i> < 0.05). A higher percentage of variability in positive emotions was explained by pain (36%) and depressive symptoms (13%) than by epidemiological characteristics (0.3%), or characteristics of IBD and its treatment (2.4%). Patients with higher levels of positive emotions (score > 3.5) experienced longer flare-free survival, also after adjusting for confounders (adjusted hazard ratio: 0.39, <i>p</i> < 0.05).</p><p><strong>Conclusions: </strong>The absence of pain and depressive symptoms were the strongest drivers for high positive affect. Higher scores of positive affect were associated with longer disease-free survival in IBD patients.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231179335"},"PeriodicalIF":4.2,"publicationDate":"2023-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/32/06/10.1177_17562848231179335.PMC10411285.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10302981","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":"Managing IBD in the COVID-19 era.","authors":"Nicholas Scalzo, Ryan C Ungaro","doi":"10.1177/17562848231176450","DOIUrl":"10.1177/17562848231176450","url":null,"abstract":"<p><p>Over the last 2 years the lives of millions have changed because of the emergence of Coronavirus disease 2019 (COVID-19). Patients living with inflammatory bowel disease (IBD) represent a sizable population with their own sets of challenges to providers in the wake of so much uncertainty. The Centers for Disease Control considers immunocompromised individuals at higher risk of infection and complications from COVID-19. Early in the pandemic, the specific risks for IBD patients were unclear as guidance was based on expert opinion regarding the management of IBD during a COVID-19 era. Fortunately, after considerable work in the field, the overwhelming evidence suggests that IBD patients as a whole do not appear to be at increased risk for more severe disease from COVID-19. Certain risk factors such as age, steroids, comorbidities, combination immunomodulatory therapy, and IBD disease activity have been associated with worse outcomes. Most IBD medications are low risk, with the exception of immunomodulator monotherapy and combination therapy with thiopurine and anti-TNF. Vaccination remains safe and effective for all IBD patients, although additional booster doses may be necessary, particularly in patients taking anti-TNF agents.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231176450"},"PeriodicalIF":4.2,"publicationDate":"2023-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1a/53/10.1177_17562848231176450.PMC10273097.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10351474","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":"Artificial intelligence in endoscopic ultrasonography: risk stratification of gastric gastrointestinal stromal tumors.","authors":"Yi Lu, Lu Chen, Jiachuan Wu, Limian Er, Huihui Shi, Weihui Cheng, Ke Chen, Yuan Liu, Bingfeng Qiu, Qiancheng Xu, Yue Feng, Nan Tang, Fuchuan Wan, Jiachen Sun, Min Zhi","doi":"10.1177/17562848231177156","DOIUrl":"10.1177/17562848231177156","url":null,"abstract":"<p><strong>Background: </strong>Previous studies have identified useful endoscopic ultrasonography (EUS) features to predict the malignant potential of gastrointestinal stromal tumors (GISTs). However, the results of the studies were not consistent. Artificial intelligence (AI) has shown promising results in medicine.</p><p><strong>Objectives: </strong>We aimed to build a risk stratification EUS-AI model to predict the malignancy potential of GISTs.</p><p><strong>Design: </strong>This was a retrospective study with external validation.</p><p><strong>Methods: </strong>We developed two models using EUS images from two hospitals to predict the GIST risk category. Model 1 was the four-category risk EUS-AI model, and Model 2 was the two-category risk EUS-AI model. The diagnostic performance of the models was validated with external cohorts.</p><p><strong>Results: </strong>A total of 1320 images (880 were very low-risk, 269 were low-risk, 68 were intermediate-risk, and 103 were high-risk) were finally chosen for building the models and test sets, and a total of 656 images (211 were very low-risk, 266 were low-risk, 88 were intermediate-risk, and 91 were high-risk) were chosen for external validation. The overall accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the four-category risk EUS-AI model in the external validation sets by tumor were 74.50%, 55.00%, 79.05%, 53.49%, and 81.63%, respectively. The accuracy, sensitivity, specificity, PPV, and NPV for the two-category risk EUS-AI model for the prediction of very low-risk GISTs in the external validation sets by tumor were 86.25%, 94.44%, 79.55%, 79.07%, and 94.59%, respectively.</p><p><strong>Conclusion: </strong>We developed a EUS-AI model for the risk stratification of GISTs with promising results, which may complement current clinical practice in the management of GISTs.</p><p><strong>Registration: </strong>The study has been registered in the Chinese Clinical Trial Registry (No. ChiCTR2100051191).</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231177156"},"PeriodicalIF":3.4,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c3/59/10.1177_17562848231177156.PMC10233610.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10301639","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":"Resolution rates in clinical trials for microbiota restoration for recurrent <i>Clostridioides difficile</i> infection: an updated systematic review and meta-analysis.","authors":"Raseen Tariq, Darrell S Pardi, Sahil Khanna","doi":"10.1177/17562848231174293","DOIUrl":"10.1177/17562848231174293","url":null,"abstract":"<p><strong>Background: </strong>Microbiota restoration is highly effective to treat recurrent <i>Clostridioides difficile</i> infection (CDI) in observational studies (cure rates >90%) but efficacy in controlled clinical trials appears to be lower.</p><p><strong>Objectives: </strong>To perform an updated meta-analysis to assess the efficacy of microbiota restoration for recurrent CDI in open-label registered prospective clinical trials compared to randomized controlled trials (RCTs).</p><p><strong>Design: </strong>A systematic review and meta-analysis was conducted.</p><p><strong>Data sources and methods: </strong>A systematic search of various databases was performed up to July 2022 to identify studies of interest. Clinical trials of microbiota restoration for recurrent CDI with clinical resolution with one dose were included. We calculated weighted pooled rates (WPRs) with 95% confidence intervals (CIs).</p><p><strong>Results: </strong>In all, 19 clinical trials with 1176 recurrent CDI patients were included. Of the patients treated with microbiota restoration, 897 experienced a clinical cure with a single microbiota restoration therapy (WPR, 78%; 95% CI, 71-85%). There was significant heterogeneity among studies with an <i>I</i>² of 88%. Analysis of trials with a control arm (non-microbiota restoration) revealed CDI resolution in 373 of 523 patients (WPR, 72%; 95% CI, 60-82%) with microbiota restoration. Among the nine open-label clinical trials, CDI resolution was seen in 524 of 653 patients after initial microbiota restoration (WPR, 84%; 95% CI, 74-92%). Comparison of resolution rates between RCTs and open-label trials revealed a lower cure rate in RCTs compared to open-label trials (WPR, 73 <i>versus</i> 84%, <i>p</i> < 0.0001).</p><p><strong>Conclusions: </strong>Microbiota restoration in a randomized controlled setting leads to lower resolution rates compared to open label and observational settings, likely due to stricter definitions and inclusion criteria. Resolution rates in open-label studies were similar to observational studies.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231174293"},"PeriodicalIF":4.2,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/4a/10.1177_17562848231174293.PMC10236242.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9570689","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}