Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis

NCT05481619 · Second Affiliated Hospital, School of Medicine, Zhejiang University

Recruiting

In plain English

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Official title

Changes in Intestinal Microecology Before and After Vedolizumab Treatment for Ulcerative Colitis and Correlation With Efficacy

About this study

Stool and blood samples etc. were taken from a cohort of patients with ulcerative colitis treated with Vedolizum at the Department of Gastroenterology, Second Affiliated Hospital of Zhejiang University School of Medicine as well as from a cohort of normal volunteers. Stool and blood samples from UC patients were analyzed at baseline and at 14, 30, and 52 weeks after starting treatment. Analysis of changes in gut microbial composition and abundance, gut and serum metabolome characteristics during 52 weeks of treatment in patients with UC. A model for predicting the efficacy of vedolizumab treatment by baseline gut microbial composition and abundance, and gut and serum metabolomic characteristics in patients with ulcerative colitis was developed in conjunction with clinical information from patients in the cohort. Based on the model developed, clinical and gut microbial composition and abundance, gut and serum metabolomics data from other UC patients published in public databases were combined to confirm the results already found using the UC cohort at our center.

Eligibility criteria

Inclusion Criteria: 1. 18 years of age or older, with moderate to severe ulcerative colitis, with an indication for vedolizumab treatment; 2. Consent to participate in the study, read and sign the informed consent form; 3. No previous treatment with vedolizumab; 4. Never undergone biologic therapy or at least suspended previous biologic therapy for more than 12 weeks; 5. Not taking antibiotics or probiotics within the past 4 weeks. Exclusion Criteria: 1. younger than 18 years of age; 2. pregnant or breastfeeding women; 3. patients who require the assistance of a surrogate, witness, or who are otherwise unable to complete the trial unaided; 4. other conditions that, in the opinion of the investigator, are unsuitable for enrollment or affect the subject's ability to complete the study; 5. have taken antibiotics or probiotics within the past 4 weeks; 6. have received prior treatment with vedolizumab.

Study design

Enrollment target: 30 participants

Allocation: non_randomized

Masking: single

Age groups: adult, older_adult

Timeline

Starts: 2021-01-01

Estimated completion: 2026-01-01

Last updated: 2025-07-25

Interventions

Drug: Vedolizumab

Primary outcomes

• Remission rate of patients (1 year)

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University · other

Contacts & investigators

ContactQiao Yu, phd · contact · yuqiao@zju.edu.cn · 0086-13456820567

InvestigatorYan Chen · principal_investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

All locations (1)

Second Affiliated Hospital Zhejiang University School of MedicineRecruiting

Zhengzhou, Hangzhou, China

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