Condition: Ulcerative Colitis · Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
This description comes directly from the study's public registry record.
Yan Chen, PhD · chenyan72_72@zju.edu.cn
Qiao Yu, PhD · +86 13456820567 · yuqiao@zju.edu.cn
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| 2nd Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou, Zhejiang, China | Not Yet Recruiting |
| Huzhou City Central Hospital | Huzhou, Zhejiang, China | Not Yet Recruiting |
| Jinhua City Central Hospital | Jinhua, Zhejiang, China | Not Yet Recruiting |
| Quzhou City People's Hospital | Quzhou, Zhejiang, China | Not Yet Recruiting |
| The Second Affiliated Hospital, Wenzhou Medical University | Wenzhou, Zhejiang, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06609447