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

NCT05481619 | Recruiting Phase 4

• 1 other identifier: I20210001091
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Remission rate of patients

  Clinical remission response rates（Mayo score≤2）

  1 year

Secondary Outcomes (2)

• Baseline gut microbial composition and abundance of patients

  1 year

• Gut and serum metabolome characteristics of UC patients

  1 year

Study Arms (2)

Group of UC patients treated with vedolizumab

ACTIVE COMPARATOR

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

Drug: Vedolizumab

Normal control group

NO INTERVENTION

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

Interventions

Vedolizumab 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.

Group of UC patients treated with vedolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older, with moderate to severe ulcerative colitis, with an indication for vedolizumab treatment;
• Consent to participate in the study, read and sign the informed consent form;
• No previous treatment with vedolizumab;
• Never undergone biologic therapy or at least suspended previous biologic therapy for more than 12 weeks;
• Not taking antibiotics or probiotics within the past 4 weeks.

You may not qualify if:

• younger than 18 years of age;
• pregnant or breastfeeding women;
• patients who require the assistance of a surrogate, witness, or who are otherwise unable to complete the trial unaided;
• other conditions that, in the opinion of the investigator, are unsuitable for enrollment or affect the subject's ability to complete the study;
• have taken antibiotics or probiotics within the past 4 weeks;
• have received prior treatment with vedolizumab.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital Zhejiang University School of Medicine

Zhengzhou, Hangzhou, 310000, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Yan Chen

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiao Yu, phd

CONTACT

0086-13456820567; yuqiao@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 1, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: now is available
• Access Criteria: All the doctors

Locations

CN (1)