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RECRUITING
NCT06609447
PHASE4

The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

An imbalance in the gut microbiota and mucosal immune dysfunction leading to intestinal inflammation are central to the pathogenesis of ulcerative colitis (UC). Both international and domestic inflammatory bowel disease (IBD) guidelines consistently recommend the use of the probiotic VSL#3 for inducing or maintaining remission in cases of mild-to-moderate UC. While the development of biologic therapies in recent years has provided new directions for IBD treatment, classic biologics such as infliximab may increase the risk of opportunistic infections and malignancies. Vedolizumab, when used for the induction therapy of UC, has a response rate of less than 80%, a slightly slower onset of action, and a slight increase in Clostridioides difficile infection (CDI) incidence. Currently, there is a lack of clinical data on the adjunctive use of VSL#3 with biologic agents in the treatment of UC globally. Therefore, this project aims to design a multi-center, randomized, placebo-controlled, double-blind study. The primary objective is to compare the changes in clinical response in patients with moderately active UC treated with either VSL#3 or placebo in combination with vedolizumab (VDZ) for six weeks.

Official title: A Multicenter Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-09-21

Completion Date

2027-12-31

Last Updated

2024-09-24

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

VSL#3

VSL#3 450 billion CFU/sachet

DIETARY_SUPPLEMENT

Placebo

Placebo sachets with maltose, cornstarch and dioxide

DRUG

Vedolizumab

Patients will start combined therapy with vedolizumab and VSL#3 or placebo at the same time. Vedolizumab will be administered according to clinical practice with the following schedule: 300 mg intravenously on Baseline (Day 1 / Week 0) and Weeks 2, 6, and 14, with a flexibility of ±3 days relative to the start of VSL#3 administration.

Locations (12)

The Seventh Medical Center, PLA General Hospital

Beijing, Beijing Municipality, China

Chongqing General Hospital

Chongqing, Chongqing Municipality, China

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, China

2nd Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Huzhou City Central Hospital

Huzhou, Zhejiang, China

Jinhua City Central Hospital

Jinhua, Zhejiang, China

Quzhou City People's Hospital

Quzhou, Zhejiang, China

The Second Affiliated Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, China