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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
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
Conditions
Interventions
VSL#3
VSL#3 450 billion CFU/sachet
Placebo
Placebo sachets with maltose, cornstarch and dioxide
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