Annals of Gastroenterology最新文献

{"title":"Device failures and patient-related adverse events with small bowel capsule endoscopy: a 20-year MAUDE database analysis.","authors":"Eric S Tatro, Sherif E Elhanafi, Douglas G Adler, Andrew C Stuart, Marc J Zuckerman","doi":"10.20524/aog.2025.0988","DOIUrl":"10.20524/aog.2025.0988","url":null,"abstract":"<p><strong>Background: </strong>Small bowel capsule endoscopy (SBCE) is a critical tool in the evaluation of small bowel bleeding, detection of small bowel neoplasms and diagnosing Crohn's disease. The object of this study was to examine device failures (DF) and patient-related adverse events (PRAE) in SBCE, including those involving the patency capsule system, using user-generated reports from the US Food and Drug Administration's (FDA) Manufacturer and User facility Device Experience (MAUDE) database.</p><p><strong>Method: </strong>We analyzed post marketing surveillance data for SBCE data for all of the SBCE systems from the FDA's MAUDE database from January 2000 until December 2023.</p><p><strong>Results: </strong>A total of 352 reports were obtained during the study period, pertaining to the following SBCE systems, in descending order of frequency: Pillcam SB^® system, Pillcam^® Patency Capsule, Endocapsule^®, CapsoCam^® and MiroCam^®. The vast majority pertained to the Pillcam^® and Pillcam^® Patency system: a total of 307 medical device reports with 398 DFs and 569 PRAEs. The most reported DFs were entrapment of the device (n=212, 53.2%), failure to transmit record (n=38, 9.5%), and failure to record (n=35, 8.7%). The most commonly reported PRAEs were a foreign body retained in the patient (n=140, 24.6%), unintentional exposure to radiation (n=104, 18.2%), and unintended exposure to anesthesia (n=58, 10.2%).</p><p><strong>Conclusions: </strong>Findings from the MAUDE database regarding SBCE devices provide valuable information on DFs and PRAEs. This knowledge can help operators optimize patient selection and reduce patient risk.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"497-504"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039074","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of upadacitinib in ulcerative colitis patients with prior tofacitinib exposure: a systematic review and meta-analysis.","authors":"Fariha Hasan, Ayesha Liaquat, Ahmed Raza, Zain Ali Nadeem, Fatima Farooqi, Hassam Ali, Dushyant Singh Dahiya, Zeina Issa, Bhanu Siva Mohan Pinnam, Saqr Alsakarneh, Islam Mohamad, Gursimran S Kocchar","doi":"10.20524/aog.2025.0991","DOIUrl":"10.20524/aog.2025.0991","url":null,"abstract":"<p><strong>Background: </strong>Upadacitinib, a selective Janus kinase (JAK) inhibitor, is a recently approved therapy for moderate-to-severe ulcerative colitis (UC). Limited data are available on its efficacy in patients previously exposed to tofacitinib, a non-selective JAK inhibitor. Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy of upadacitinib in UC patients with prior tofacitinib treatment.</p><p><strong>Methods: </strong>PubMed, Embase, Web of Science, and Cochrane Library were queried for studies evaluating the effectiveness of upadacitinib in UC patients with prior tofacitinib treatment. Primary outcomes included clinical remission, steroid-free clinical remission (SFCR), and clinical response. Secondary outcomes were the mean decrease in fecal calprotectin, and adverse events. Statistical analyses were performed using R, calculating pooled proportions with 95% confidence intervals (CI) for dichotomous outcomes and mean differences with 95%CI for continuous outcomes using a random-effects model.</p><p><strong>Results: </strong>Five studies, with 127 patients, were included in the final analysis. Upadacitinib increased pooled clinical remission rates by 57% (95%CI 0.32-0.80), SFCR rates by 52% (95%CI 0.26-0.78), and clinical response rates by 75% (95%CI 0.44-0.96). Upadacitinib reduced mean fecal calprotectin levels by 597.59% (95%CI 350.94-844.324). Adverse events, such as headache, acne vulgaris, rash, nasopharyngitis and infections, were reported in 34% of patients (95%CI 0.11-0.62).</p><p><strong>Conclusions: </strong>Our meta-analysis indicates that upadacitinib may be an effective treatment for patients with prior tofacitinib exposure, demonstrating significant clinical remission, SFCR, and clinical response. Larger clinical trials are needed to establish long-term outcomes.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"511-518"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421357/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of prophylactic pancreatic stents in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a 16-year comprehensive study.","authors":"Gregorios Paspatis, Ioannis Psaroudakis, Magdalini Velegraki, Maria Fragaki, Despoina-Eleni Arna, George Tribonias, Evangelos Voudoukis, Angeliki Theodoropoulou, Gregorios Chlouverakis, Emmanouil Vardas","doi":"10.20524/aog.2025.0996","DOIUrl":"10.20524/aog.2025.0996","url":null,"abstract":"<p><strong>Background: </strong>Cannulation of the common bile duct (CBD) during endoscopic retrograde cholangiopancreatography (ERCP) can be technically challenging, especially when repeated unintended pancreatic duct cannulation occurs. We evaluated the effectiveness of prophylactic pancreatic stent (PS) placement in preventing post-ERCP pancreatitis (PEP) under such conditions. This is the first comprehensive study of its kind conducted in Greece, and one of the few in Europe.</p><p><strong>Methods: </strong>This retrospective study included patients who underwent their first ERCP between January 1, 2008, and March 1, 2024, and received a PS after inadvertent pancreatic duct cannulation on 3 or more attempts. From 2015 onward, rectal diclofenac was administered to all patients as a preventive measure for PEP.</p><p><strong>Results: </strong>In a total of 6080 ERCP procedures, 421 patients met the inclusion criteria (46.1% male; mean age 67.8±15.8 years). The most common indications were choledocholithiasis (57.7%), malignant obstruction (26.6%), and benign CBD strictures (5.7%). Successful CBD cannulation during the initial session was achieved in 86.4% of cases. Additional techniques included transpancreatic sphincterotomy (2.6%) and needle-knife precut (1.4%). A second ERCP was performed in 7.8% of cases, achieving successful CBD cannulation in all. PEP occurred in 4.9% of patients, with severe cases accounting for only 0.7%. PEP was significantly more frequent in women (P=0.001), while diclofenac did not significantly reduce its incidence (P=0.4). There were 3 deaths, 1 related to PEP (0.2%).</p><p><strong>Conclusion: </strong>PS placement effectively reduces severe PEP risk following difficult CBD cannulation and supports high success rates in repeat ERCP, while diclofenac showed no significant additional benefit.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"570-576"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Managing inflammatory bowel disease in patients receiving cancer-associated chemotherapy and beyond.","authors":"Courtenay Ryan-Fisher, Stefan Thorarensen, Ruchir Paladiya, Haleh Vaziri","doi":"10.20524/aog.2025.0998","DOIUrl":"10.20524/aog.2025.0998","url":null,"abstract":"<p><p>Managing patients with inflammatory bowel disease (IBD) and a current or previous history of cancer is becoming increasingly common. This scoping review aims to provide an up-to-date overview of the available literature on the management of IBD in cancer patients, including those in remission and those undergoing active cancer treatment. This scoping review was conducted, using PubMed, EMBASE and Scopus, to identify studies on IBD management in adult patients with active or prior malignancy, published between January 2019 and July 2024. Search terms included \"inflammatory bowel disease\" and \"malignancy\". Thirty-three studies met the criteria for inclusion; most were retrospective cohort studies. Seventeen studies analyzed incident risk of new or recurrent malignancy after starting IBD medications in patients with prior cancer. Most of these studies suggest a limited risk of cancer recurrence after restarting IBD medications. The remaining studies looked at IBD patients receiving active cancer therapy, assessing the risk of IBD relapse and/or the side effects of cancer therapy in IBD patients. Most IBD patients treated with cytotoxic chemotherapy did not experience relapse of IBD activity during therapy. However, those on either hormonal chemotherapies or immune checkpoint inhibitors were more likely to experience IBD relapse, although the data are inconsistent. This review highlights the limited cancer recurrence risk associated with IBD therapies in cancer patients. Individualized, multidisciplinary approaches are essential for managing IBD in patients with a history of cancer. Future research should prioritize large-scale prospective studies to guide IBD and cancer management.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"472-487"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends and outcomes of endoscopic ultrasound-guided drainage and pancreatic necrosectomy for acute necrotizing pancreatitis.","authors":"Osayande Osagiede, Andrea Gomez Pons, Bhaumik Brahmbhatt, Vivek Kumbhari, Frank Lukens","doi":"10.20524/aog.2025.0987","DOIUrl":"10.20524/aog.2025.0987","url":null,"abstract":"<p><strong>Background: </strong>Use of endoscopic ultrasound (EUS)-guided interventions has resulted in an expanding domain of non-surgical endoscopic methods for treating acute necrotizing pancreatitis (ANP). We examined the current trends and outcomes of EUS-guided drainage and endoscopic necrosectomy in the United States.</p><p><strong>Methods: </strong>This observational retrospective study used the Nationwide Inpatient Sample database (2016-2020) to identify adult patients with ANP who underwent endoscopic necrosectomy, based on ICD-10-CM codes. Univariate and multivariate logistic regression, and linear models were used to examine the outcomes of ANP in patients who underwent endoscopic necrosectomy in comparison to patients who had no such interventions.</p><p><strong>Results: </strong>Among 11,212 ANP cases identified, 493 (4.4%) underwent endoscopic necrosectomy. The patients' mean age was 49.6 years and they were predominantly male (66.8%). There was a steady increase in ANP admissions (542 to 3180) and endoscopic necrosectomy (0% to 5.8%) from 2016-2020. Endoscopic intervention had lower odds for systemic inflammatory response syndrome (P=0.038), but higher odds for venous thromboembolism (P=0.006). Hospital costs (P<0.001), charges (P<0.001), and length of hospital stay (LOS) (P<0.001) were greater for patients with endoscopic intervention. Procedural adverse events were rare (5.9%), and were associated with significantly greater LOS (P=0.004), higher hospital costs (P=0.018) and charges (P=0.004), but no difference in mortality (P=0.899).</p><p><strong>Conclusions: </strong>Endoscopic necrosectomy for ANP increased from 2016-2020 and was associated with low risk for adverse events or mortality, but greater LOS and costs compared to conservative non-interventional management. Further research is required to optimize patient selection and address the economic implications.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"564-569"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421356/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Authors' reply.","authors":"Sheza Malik, Ese Uwagbale, Olayemi A Adeniranc, Arshia Sethi, Raseen Tariq","doi":"10.20524/aog.2025.0986","DOIUrl":"10.20524/aog.2025.0986","url":null,"abstract":"","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"577-578"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The therapeutic benefits of epigallocatechin gallate in rats with experimentally induced ulcerative colitis are achieved by influencing inflammation and apoptosis.","authors":"Abdulrhman M Al-Qarni, Abdulrhman A Eid, Abdulmajeed M Albalawi, Naif S Albalawi, Mohammed A F Elewa, Khalid S Hashem, Mohammed M H Al-Gayyar","doi":"10.20524/aog.2025.0985","DOIUrl":"10.20524/aog.2025.0985","url":null,"abstract":"<p><strong>Background: </strong>The potential therapeutic effects of epigallocatechin gallate (EGCG), a compound found in green tea with antioxidant and anti-inflammatory properties, on ulcerative colitis (UC) rats is a significant area of research. This study aimed to investigate the impact of EGCG on inflammation and apoptotic pathways in UC rats.</p><p><strong>Methods: </strong>The study involved inducing UC in rats by administering 2 mL of 4% acetic acid. The UC rats were then treated with 20 mg/kg of EGCG. Colon samples were collected to evaluate gene and protein expression of various factors, including nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB), tumor necrosis factor alpha (TNF-α), sphingosine kinase 1 (SphK1), macrophage inflammatory protein 1-alpha (MIP-1α), B-cell lymphoma 2 (BCL2), and BCL2 associated X (BAX), as well as the activities of caspase-3/8/9. Additionally, colon sections were stained with Masson trichrome to investigate tissue fibrosis.</p><p><strong>Results: </strong>Microscopic examination of rat colonic sections stained with Masson trichrome revealed severe damage to the intestinal glands, marked by widespread hemorrhage and extensive fibrosis. Treatment with EGCG reduced the severity of the damage. Additionally, EGCG decreased the expression of several proinflammatory markers, such as NFκB and TNF-α, as well as SphK1, MIP-1α and BAX, reduced caspase-3/8/9 activity, and increased the expression of BCL2.</p><p><strong>Conclusions: </strong>The protective effects of EGCG against UC experimentally induced in rats are achieved by reducing the expression of inflammatory markers such as NFκB, TNF-α and MIP-1α, inhibiting apoptosis by decreasing the expression of BAX and caspases, and increasing the expression of BCL2.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"526-536"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tertiary referral for double balloon enteroscopy in small bowel Crohn's disease: a retrospective assessment of diagnostic impact.","authors":"Daniela Fluxa, Hasan Saleh, Christian Karime, Jing Wang, Bhaumik Brahmbhatt, Frank J Lukens, Mark Stark, Michael F Picco, Jami A Kinnucan, Jana G Hashash, Francis A Farraye","doi":"10.20524/aog.2025.0995","DOIUrl":"10.20524/aog.2025.0995","url":null,"abstract":"<p><strong>Background: </strong>Diagnosing isolated small bowel Crohn's disease (CD) can be challenging, as symptoms, imaging, and capsule endoscopy (CE) can mimic other diseases. Double balloon enteroscopy (DBE) directly evaluates the small bowel. We describe the impact of tertiary referral for DBE in patients with known or suspected small bowel CD.</p><p><strong>Methods: </strong>We carried out a retrospective review of a single tertiary-center DBE database from February 2009 to May 2013. Patients referred for DBE for known or suspected small bowel CD, based on CE, imaging and/or symptoms were included. The primary outcome was the change in diagnosis and/or management after referral for DBE. A descriptive statistical analysis was performed.</p><p><strong>Results: </strong>A total of 108 patients were included, 10 with established CD and 98 with suspected/rule-out CD. DBE changed management in 8/10 patients with known CD. In patients with suspected CD, the diagnosis was confirmed in 39/98 (40%), and management was changed in 32 of those 39 (82%). An alternative diagnosis was made or CD was ruled out in 59/98 (60%) patients with suspected CD. Prior to DBE, starting CD therapy was recommended in 24/98 (25%) patients, but DBE confirmed CD in only 15 of those 24 (63%).</p><p><strong>Conclusions: </strong>Tertiary referral for DBE in suspected CD confined to the small bowel is valuable for investigating the findings from noninvasive testing, such as CE or imaging. DBE can guide CD management and establish accurate diagnoses. Physicians should consider DBE when the diagnosis of isolated small bowel CD is not confirmed by histology.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"505-510"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bezlotoxumab for the prevention of recurrent <i>Clostridioides difficile</i> infection for patients with cancer.","authors":"Jaime A Peña, Cyril B Mazhuvanchery, Maria Julia Moura Nascimento Santos, Sidra Naz, Carolina Colli Cruz, Sharada Wali, Krishnavathana Varatharajalu, Pablo C Okhuysen, Nancy N Vuong, Yinghong Wang","doi":"10.20524/aog.2025.0994","DOIUrl":"10.20524/aog.2025.0994","url":null,"abstract":"<p><strong>Background: </strong>Several clinical factors increase the susceptibility of cancer patients to <i>Clostridioides difficile</i> infection (CDI), often resulting in lower CDI treatment response rates and higher rates of recurrent CDI (rCDI). Bezlotoxumab, a monoclonal antibody targeting and neutralizing <i>C. difficile</i> toxin B, demonstrates a significant reduction in rCDI rates compared to standard of care alone in the general population. However, the effectiveness of bezlotoxumab in the cancer patient population requires further investigation. We assessed the incidence of rCDI within 90 days of bezlotoxumab treatment in patients with cancer.</p><p><strong>Methods: </strong>This was a single-center retrospective cohort study conducted at a tertiary care cancer center, including patients who received bezlotoxumab with standard-of-care antibiotics for CDI or rCDI between March 2016 and January 2023. Descriptive analyses were conducted.</p><p><strong>Results: </strong>A total of 177 patients with cancer who received bezlotoxumab were included. Most (76.8%) experienced <2 CDI episodes, whereas 23.2% experienced ≥2 episodes. Bezlotoxumab was administered a median of 10 days (interquartile range [IQR] 5-12.5) after symptom onset, and fidaxomicin was the most frequently used concurrent antibiotic (41.2%). Eleven patients (6.2%) underwent fecal microbiota transplantation before or after bezlotoxumab treatment. The overall 90-day rCDI recurrence rate was 6.2% (11 patients), with a median time to recurrence of 50 days (IQR 25-58).</p><p><strong>Conclusions: </strong>Bezlotoxumab demonstrated high efficacy in reducing rCDI within a 90-day period after administration, compared to rates in the non-cancer population. The findings suggest that administration of bezlotoxumab for rCDI prevention should be considered, given the improvement in the outcome of this high-risk group.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"519-525"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disparities in the burden of gastrointestinal diseases: a comprehensive analysis of data from randomized clinical trials from 2000-2023.","authors":"Wissam Ghusn, Khushboo Gala, Rudy Mrad, Marita Salame, Serena J Rahme, Hector Reyes Santiago, Arpan Mohanty, Laura Chiu, Jana G Hashash, Victor Chedid","doi":"10.20524/aog.2025.0997","DOIUrl":"10.20524/aog.2025.0997","url":null,"abstract":"<p><strong>Background: </strong>Gastrointestinal (GI) conditions, such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), metabolic dysfunction-associated steatotic liver disease (MASLD), and gastroesophageal reflux disease (GERD) are major contributors to morbidity and the healthcare burden. Randomized controlled trials (RCTs) are essential for advancing evidence-based medicine, but disparities in participant recruitment often limit the generalizability of trial findings. This study aimed to investigate demographic disparities in GI-related clinical trials, comparing trial populations to real-world data in order to identify gaps in recruitment.</p><p><strong>Methods: </strong>A cross-sectional analysis was conducted using data from United States RCTs from 2000-2023 that focused on major GI conditions: IBD, IBS, MASLD, and GERD. Demographic variables, including age, sex, gender, race and ethnicity, were collected and compared to real-world data from national health surveys. Descriptive statistics summarized the demographic distribution within the trials and highlighted disparities.</p><p><strong>Results: </strong>The analysis revealed significant disparities in recruitment across multiple GI conditions. Despite the growing burden of chronic diseases in older populations, older adults were underrepresented across trials, as a majority of participants were aged between 18 and 65 years. Sex and gender disparities were also observed, with underrepresentation of females in IBD trials and overrepresentation in IBS and MASLD trials, and no representation of gender diverse individuals. White participants were mostly overrepresented, while Black, Asian, and Hispanic individuals were underrepresented in several trials.</p><p><strong>Conclusion: </strong>This study underscores the need for more inclusive recruitment strategies in clinical trials to ensure diverse representation across age, sex, gender, and race.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"488-496"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}