Clinical and Translational Gastroenterology最新文献

{"title":"Mucin 5AC as a Biomarker for Sessile Serrated Lesions: Results From a Systematic Review and Meta-Analysis.","authors":"Kevin Liu, Moniyka Sachar, Violeta Popov, Ziheng Pei, Giulio Quarta","doi":"10.14309/ctg.0000000000000831","DOIUrl":"10.14309/ctg.0000000000000831","url":null,"abstract":"<p><strong>Introduction: </strong>Sessile serrated lesions (SSLs) are a class of colon polyps challenging to detect through current screening methods but highly associated with colon cancer. To improve detection, we sought a biomarker sensitive for SSLs. Recent endoscopic and histopathologic studies suggest that SSLs are associated with alterations in intestinal mucin expression, but the frequency with which this occurs is not known.</p><p><strong>Methods: </strong>We performed a meta-analysis of available pathologic studies comparing mucin expression on SSLs to normal colonic mucosa, tubular adenomas, villous adenomas, traditional serrated adenomas (TSAs), and hyperplastic polyps (HPs). We searched Medline, Pubmed, and Embase and found 440 publications in this topic, and 18 total studies met inclusion.</p><p><strong>Results: </strong>We found that MUC5AC expression was more common in SSLs compared to normal colonic mucosa (OR = 82.9, P < 0.01), tubular adenoma (OR = 11, P < 0.01), and TSAs (OR = 3.6, P = 0.04). We found no difference in MUC5AC expression between SSLs versus HPs (OR = 2.1, P = 0.09) and no difference in MUC5AC expression between left colon and right colon HPs, with an OR = 1.8, P = 0.23.</p><p><strong>Discussion: </strong>We found that MUC5AC expression was found commonly on villous adenoma, SSLs, and TSAs while the frequency on colon cancers declined. MUC5AC is also upregulated in inflammatory bowel disease and in response to intestinal infections. MUC5AC expression highlights the potential of mucins as useful biomarkers, though not specific to SSLs. Further research into the clinical utility of MUC5AC as a pathologic or fecal biomarker could enhance SSL detection.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Healthcare Providers' Perspectives on Anoreceptive Intercourse in Sexual and Gender Minorities With Ileal Pouch Anal Anastomosis.","authors":"Darine Daher, Kira L Newman, Rachel Canning, Sherief Shawki, Jana G Hashash, Sunanda Kane, Daniela Guerrero Vinsard, Victor Chedid","doi":"10.14309/ctg.0000000000000838","DOIUrl":"10.14309/ctg.0000000000000838","url":null,"abstract":"<p><strong>Introduction: </strong>Evidence-based recommendations for sexual practices regarding anoreceptive intercourse (ARI) do not exist in patients with inflammatory bowel diseases undergoing restorative proctocolectomy with ileal pouch anal anastomosis (IPAA). This study surveys providers on perspectives and attitudes related to sexual practices after IPAA.</p><p><strong>Methods: </strong>We developed a 23-item survey and distributed it to providers caring for patients with inflammatory bowel diseases.</p><p><strong>Results: </strong>95% of providers believe that it is important to discuss sexual orientation or practices before IPAA, but only 27% routinely discuss this. 50% did not feel comfortable and 74% did not feel confident discussing ARI recommendations with patients who underwent or will undergo IPAA.</p><p><strong>Discussion: </strong>Future interventions should aim to standardize recommendations regarding feasibility and time line to safe ARI after IPAA.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nomogram Prediction for Gastric Cancer Development.","authors":"Joo Hyun Lim, Areum Han, Soo-Jeong Cho, Seokyung Hahn, Sang Gyun Kim","doi":"10.14309/ctg.0000000000000833","DOIUrl":"10.14309/ctg.0000000000000833","url":null,"abstract":"<p><strong>Introduction: </strong>Helicobacter pylori ( Hp ) and gastric atrophy represent significant risk factors for gastric cancer (GC). Nevertheless, to date, no nomogram has been developed to predict GC based on the specific combination of risk factors present in individual cases.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted using health screening data collected between 2003 and 2018. Subjects with positive results for anti- Hp antibody were enrolled. Individuals were classified into 4 groups: low-B (low titer without atrophy), high-B (high titer without atrophy), high-C (high titer with atrophy), and low-C (low titer with atrophy). Nomogram prediction models were developed for overall GCs as well as intestinal and diffuse cancers, with each type considered a competing event, by using both Cox proportional and subdistribution hazard models. Prediction performance was evaluated using the concordance index (c-index) and the area under the curve through 10-fold cross-validation.</p><p><strong>Results: </strong>During a median follow-up period of 5.7 years, 231 new GC cases developed among the total cohort of 28,311 subjects, including 159 intestinal type, 68 diffuse type, and 4 cases of unknown type. Multivariable analyses indicated that age, body mass index, family history, smoking, and classification into the high-C or low-C group were significant predictors of GC. The nomograms for intestinal type, diffuse type, and total GC demonstrated area under the curve values of 0.82, 0.62, and 0.75, respectively, and c-indices of 0.85, 0.54, and 0.76, respectively.</p><p><strong>Discussion: </strong>The nomograms for GC prediction would be useful in identifying high-risk individuals, particularly for intestinal type. This would facilitate the implementation of personalized eradication and intensive screening strategies to target those at higher risk for GC.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Secondary Spontaneous Bacterial Peritonitis Prophylaxis Is Associated With a Higher Rate of Infections other than Spontaneous Bacterial Peritonitis in 2 US-Based National Cirrhosis Cohorts.","authors":"Scott Silvey, Nilang Patel, Jacqueline G O'Leary, Sofia S Jakab, Heather Patton, Shari Rogal, John D Markley, Ramsey Cheung, Arpan Patel, Timothy R Morgan, Jasmohan S Bajaj","doi":"10.14309/ctg.0000000000000837","DOIUrl":"10.14309/ctg.0000000000000837","url":null,"abstract":"<p><strong>Introduction: </strong>Antibiotic overuse and subsequent antibiotic resistance lead to worse infection outcomes in cirrhosis. Secondary spontaneous bacterial peritonitis prophylaxis (SecSBBPr) is associated with higher SBP recurrence, but impact on non-SBP infections is unclear.</p><p><strong>Methods: </strong>We studied patients with cirrhosis and SBP who were given SecSBPPr or not between 2009 and 2019 in 2 complementary national cohorts (Veterans Affairs Corporate Data Warehouse [VA-CDW] and non-VA TriNetX). Development of total non-SBP infections and specifically urinary tract infections (UTIs), bacteremia, pneumonia, and C. difficile using validated codes over 2 years was compared between those on SecSBPPr vs not. Multivariable regression for non-SBP infections was performed.</p><p><strong>Results: </strong>VA-CDW: Of 4,673 veterans with index SBP, 2,539 (54.3%) were started on SecSBPPr. In total, 1,406 (30.1%) developed non-SBP infections (13.5% UTI, 12.4% pneumonia, 8.5% bacteremia, and 6.8% C. difficile ). On multivariable regression, SecSBPPr was significantly associated with any non-SBP infection (odds ratio [OR] 1.26, 95% confidence interval [CI] 1.10-1.44, P < 0.0001) and UTI (OR 1.21, 95% CI 1.01-1.45, P = 0.036). TriNetX: Of 6,708 patients with index SBP, 3,261 (48.6%) were started on SecSBPPr. In total, 1,932 (28.8%) patients developed non-SBP infections (13.4% UTI, 12.9% pneumonia, 8.6% bacteremia, and 5.9% C. difficile ). On multivariable regression, SecSBPPr was significantly associated with any non-SBP infection (OR 1.33, 95% CI 1.12-1.59, P < 0.0001), UTI (OR 1.35, 95% CI 1.07-1.71, P = 0.010), pneumonia (OR 1.35, 95% CI 1.06-1.72, P = 0.017), and bacteremia (OR 1.47, 95% CI 1.10-1.97, P = 0.009).</p><p><strong>Discussion: </strong>In 2 diverse US-based national cohorts of patients with cirrhosis and SBP, use of SecSBPPr was associated with a higher risk of non-SBP infections, especially urinary tract infections.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Decreased Subcutaneous Adipose Tissue Correlates With Higher Portal Hypertension and Poor Survival in Patients With Cirrhosis: A Retrospective Binary-Center Study.","authors":"Siwei Yang, Xiuwan Ren, Xiaoqing Guo, Jianan Yu, Lizhen Niu, Yao Niu, Linpeng Zhang, Long Jin","doi":"10.14309/ctg.0000000000000836","DOIUrl":"10.14309/ctg.0000000000000836","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to investigate the impact of hepatic venous portal gradient (HVPG) on body composition (BC) values and the prognostic value of BC value in cirrhotic patients.</p><p><strong>Methods: </strong>A total of 173 cirrhotic patients with HVPG and computed tomography scan were screened retrospectively from a binary-center database. Seven BC values, including skeletal muscle index, subcutaneous adipose tissue index (SATI), deep SATI (dSATI), superficial SATI (sSATI), visceral adipose tissue index, and ratio of visceral adipose tissue index and SATI along with skeletal muscle radiodensity, were analyzed. The correlation analyses and multiple linear regression were used to assess the impact of HVPG on BC values. The cumulative survival rate was assessed, and risk factors of survival were identified by competing risk analysis using Fine-Gray model.</p><p><strong>Results: </strong>Among 173 patients with a mean age of 53.7 ± 10.5 years, there were 111 male patients (64.2%) and 62 female patients (35.8%). In male patients, SATI, dSATI, and sSATI inversely correlated with HVPG, respectively (SATI: rho = -0.227; dSATI: rho = -0.229; sSATI: rho = -0.219; all P < 0.05), especially in patients aged 60 years or younger or with compensated cirrhosis; male patients with clinically significant portal hypertension had a lower SATI, dSATI, sSATI, and skeletal muscle radiodensity than those without clinically significant portal hypertension. After adjusted multiple linear models, male sex, Child-Pugh class B or C, and elevated HVPG contributed to decreased SATI. Multiple competing survival analysis showed a lower SATI (male: <38 cm 2 /m 2 ; female: <23 cm 2 /m 2 ), and Child-Pugh B or C predict mortality.</p><p><strong>Discussion: </strong>Decreased SATI, dSATI, and sSATI were more closely associated with increased HVPG. A lower SATI and Child-Pugh B or C predicted mortality.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Image-Based Model for Assisting in Diagnosing Malignant Esophageal Lesions During Lugol Chromoendoscopic Examination.","authors":"Mengfei Liu, Zifan Qi, Ren Zhou, Chuanhai Guo, Anxiang Liu, Haijun Yang, Fenglei Li, Liping Duan, Lin Shen, Qi Wu, Zhen Liu, Yaqi Pan, Fangfang Liu, Ying Liu, Huanyu Chen, Zhe Hu, Hong Cai, Zhonghu He, Yang Ke","doi":"10.14309/ctg.0000000000000835","DOIUrl":"10.14309/ctg.0000000000000835","url":null,"abstract":"<p><strong>Introduction: </strong>Image-based diagnostic tools that aid endoscopists to biopsy putative esophageal malignant lesions are essential for ensuring the standardization and quality of Lugol chromoendoscopy. But there is no such model available yet.</p><p><strong>Methods: </strong>We developed a diagnostic model using endoscopic Lugol-unstained lesions (LULs) features and baseline data from 1,099 individuals enrolled from a large-scale population-based ESCC screening cohort. Six hundred three participants from a clinical outpatient cohort were included as the external validation set. High-grade intraepithelial neoplasia and above lesions identified at baseline or within 1 year after screening were defined as outcome. The final model was determined using logistic regression analysis by the Akaike information criterion.</p><p><strong>Results: </strong>The optimal diagnostic model contained the size, irregularity, sharp border of LUL, age, and body mass index of the participant, with the area under the curve of 0.83 (95% confidence interval [CI]: 0.78-0.87) in the development set, 0.81 (95% CI: 0.77-0.86) in the internal validation set, and 0.87 (95% CI: 0.84-0.90) in the external set. This model stratified individuals with LULs into low-risk, moderate-risk, and high-risk groups based on tertiles of predicted probabilities. The high-risk group accounted for <40% participants but enriched 80.8% and 82.7% of high-grade intraepithelial neoplasia and above cases in the development and external validation sets, respectively, achieving detection ratios 16.2 and 11.0 times higher than the low-risk group.</p><p><strong>Discussion: </strong>Our model can help maintain consistency and accuracy in detecting esophageal malignancy through Lugol chromoendoscopy, particularly in primary healthcare units in high-risk rural areas.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Radiographic Identification of Visceroptosis in Patients With Hypermobile Ehlers-Danlos Syndrome With Functional Gastrointestinal Symptoms Compared With Healthy Subjects.","authors":"Yin Chan, Bianca W Chang, Amrit K Kamboj, Yaniv Raphael, Richard Sukov, Ali Rezaie","doi":"10.14309/ctg.0000000000000834","DOIUrl":"10.14309/ctg.0000000000000834","url":null,"abstract":"<p><strong>Introduction: </strong>Visceroptosis is a potential cause of gastrointestinal symptoms in hypermobile Ehlers-Danlos syndrome (hEDS).</p><p><strong>Methods: </strong>We systematically examined the prolapse of abdominal organs below their natural supine position (visceroptosis) during the upright small bowel barium study in healthy and hEDS subjects with irritable bowel syndrome.</p><p><strong>Results: </strong>Comparison of age- and sex-matched healthy (n = 20) and hEDS (n = 10) subjects did not show any significant difference in dynamic movement of the viscera. Subgroup analysis did not demonstrate any correlation between the degree of prolapse, clinical symptoms, and hypermobility clinical (Beighton) scores. The interobserver reliability for 3 of the 4 anatomic landmarks showed \"moderate\" or \"good\" correlation based on their interclass correlation coefficients.</p><p><strong>Discussion: </strong>Patients with hEDS do not appear to have a significantly increased incidence of visceroptosis.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disaccharidase Enzyme Deficiency in Adult Patients With Gas and Bloating.","authors":"Brendan Kemple, Satish S C Rao","doi":"10.14309/ctg.0000000000000809","DOIUrl":"10.14309/ctg.0000000000000809","url":null,"abstract":"<p><strong>Introduction: </strong>Disaccharidases produced by the small intestinal brush border facilitate digestion of dietary carbohydrates. If deficient, they can cause carbohydrate malabsorption, resulting in several abdominal symptoms. Our aim was to examine the prevalence of disaccharidase deficiency and correlate this with abdominal symptoms in adult patients with chronic abdominal symptoms.</p><p><strong>Methods: </strong>In a retrospective study, patients with gas and bloating and normal endoscopy and computed tomography scan were assessed for lactase, sucrase, maltase, palatinase, and glucoamylase activity. Nine common symptoms such as pain, cramping, constipation, belching, bloating, fullness, indigestion, nausea, diarrhea, vomiting, and gas were assessed for their frequency, intensity, and duration using a validated scale, and a total symptom index was calculated and compared. K-means cluster analysis was performed on lactase-deficient and pandeficient patients with deficiency in 3 or more enzymes.</p><p><strong>Results: </strong>Four hundred ninety-six patients (78.4% female) were enrolled of whom 143 (28.8%) had single enzyme deficiency, 9 (1.8%) had double enzyme deficiency, and 48 (9.7%) were pandeficient. The mean symptom prevalence and its severity were not significantly different between those with or without disaccharidase deficiency. Patients with pandeficiency did not have worse symptoms than those with single or double enzyme deficiency. No single symptom was more prevalent in patients with confirmed enzyme deficiency than those without. Three groups were identified in cluster analysis of pandeficient patients with one group demonstrating significantly lower average symptoms of cramping, indigestion, and nausea.</p><p><strong>Discussion: </strong>Disaccharidase deficiency is common in adults presenting with gas, bloating, distention, and pain. Because these deficiencies are treatable with enzyme supplements or diet, an evaluation for disaccharidase deficiency should be routinely considered.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00809"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11932595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945647","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":"Treatment of Bile Acid Diarrhea With Glucagon-Like Peptide 1 Receptor Agonists: A Promising Yet Understudied Approach.","authors":"Anne-Marie Ellegaard, Martin L Kårhus, Matilde Winther-Jensen, Asger B Lund, Filip K Knop","doi":"10.14309/ctg.0000000000000815","DOIUrl":"10.14309/ctg.0000000000000815","url":null,"abstract":"<p><p>Bile acid diarrhea (BAD) is a chronic and socially debilitating disease characterized by abdominal pain, diarrhea, urgency, and fecal incontinence. Recently, in a 6-week randomized controlled trial, we showed that the glucagon-like peptide 1 receptor agonist (GLP-1RA) liraglutide is superior to bile acid sequestration (considered standard-of-care) using colesevelam in reducing BAD symptoms. The emergence of new, more potent, and longer-acting GLP-1RAs has spurred an interest in these treatments in BAD management. Here, we review the literature on different GLP-1RAs in BAD treatment and outline their potential mode of actions, highlight knowledge gaps, and outline the need for further clinical evidence generation.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00815"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11932613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142977890","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":"Vidofludimus Calcium in Patients With Moderate-to-Severe Ulcerative Colitis: A Randomized, Placebo-Controlled, Phase 2 Trial.","authors":"Geert D'Haens, Kalina Grivcheva Stardelova, Edite Sadiku, Natallia Kizlova, Syitlana Skybalo, Yulia Shehovtsova, Mirela Abramescu, Daniel Vitt, Hella Kohlhof, Andreas Muehler","doi":"10.14309/ctg.0000000000000813","DOIUrl":"10.14309/ctg.0000000000000813","url":null,"abstract":"<p><strong>Introduction: </strong>Vidofludimus calcium (VidoCa) is a dihydroorotate dehydrogenase inhibitor that demonstrated efficacy in immune-related diseases. This study assessed the safety and efficacy of VidoCa in patients with active ulcerative colitis (UC).</p><p><strong>Methods: </strong>This placebo-controlled, phase 2 trial randomized adults with moderate-to-severe UC to receive once-daily VidoCa (10, 30, or 45 mg) or placebo for 10 weeks (induction); patients with symptomatic remission were rerandomized to VidoCa 10, 30 mg, or placebo once daily for an additional 40 weeks (maintenance). The primary endpoint was clinical remission at week 10. Secondary endpoints included symptomatic remission, endoscopic healing, and symptomatic response. The study is registered with ClinicalTrials.gov (NCT03341962) and EudraCT (2017-003703-22).</p><p><strong>Results: </strong>Two hundred sixty-three patients were randomized to induction treatment with VidoCa (10 mg [n = 67], 30 mg [n = 66], and 45 mg [n = 66]) or placebo (n = 64). Sixteen (14%) patients treated with VidoCa (30 mg or 45 mg) achieved the primary endpoint compared with 8 (14%) with placebo. In patients without concomitant corticosteroids, 7 (12%) treated with VidoCa achieved clinical remission at week 10 vs 1 (4%) with placebo. At week 50, dose-dependent increases in the rate of clinical remission ( P = 0.0358), steroid-free clinical remission, and endoscopic healing were observed. Common adverse events (AEs) were headache (4 [6%]), anemia (3 [6%]), vomiting (3 [5%]), and hypertension (3 [5%]) with incidence similar between placebo and VidoCa. Hematuria (4 [6%]) was a treatment-related AE with VidoCa 45 mg only. The incidence of serious AEs was low.</p><p><strong>Discussion: </strong>VidoCa was safe, well-tolerated, and demonstrated proof-of-concept for dihydroorotate dehydrogenase inhibition to treat UC.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00813"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11932581/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945602","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}