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

NCT ID: NCT05481619

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-01-01

Brief Summary

Inflammatory bowel disease is a group of chronic, non-specific inflammatory diseases of the intestinal tract whose etiology has not yet been fully elucidated, including ulcerative colitis and Crohn's disease. Vedolizumab, a novel biologic agent, is a recombinant humanized monoclonal antibody that specifically antagonizes intestine-selective α4β7 integrins on the surface of leukocyte subsets, thereby preventing migration of leukocyte subsets from the blood to the intestinal mucosa and reducing local inflammation in the gut. In this study the investigators propose to build on an existing cohort and analyse, by means of a multi-omics approach, the baseline gut microbial composition and abundance, intestinal and serum metabolome characteristics of UC patients and their changes during treatment, to predict the functional mechanisms by which these changing characteristics influence the therapeutic response to vindolizumab.

Detailed Description

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group of UC patients treated with vedolizumab

Generic Name：vedolizumab Specification：300mg/bottle Dosage and Method of Administration：Usual adult dose for ulcerative colitis.300 mg IV every 30 minutes at weeks 0, 2, and 6, then every 8 weeks

Group Type: ACTIVE_COMPARATOR

Vedolizumab

Intervention Type: DRUG

Recommended dose in patients with UC: 300 mg intravenously at weeks 0, 2, and 6 and every 8 weeks thereafter.

Discontinue vedolizumab at week 14 in patients who do not show treatment benefit.

Normal control group

On the basis of the exclusion criteria, there are no significant intestinal inflammatory, autoimmune or neoplastic disorders.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vedolizumab

Recommended dose in patients with UC: 300 mg intravenously at weeks 0, 2, and 6 and every 8 weeks thereafter.

Discontinue vedolizumab at week 14 in patients who do not show treatment benefit.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Chen

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

Second Affiliated Hospital Zhejiang University School of Medicine

Zhengzhou, Hangzhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiao Yu, phd

Role: CONTACT

yuqiao@zju.edu.cn

0086-13456820567

Facility Contacts

Qiao Yu, PhD

Role: primary

yuqiao@zju.edu.cn

13456820567

Other Identifiers

I20210001091

Identifier Type: -

Identifier Source: org_study_id