Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609447
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
The Efficacy and Safety of Combining Probiotic VSL3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Combining Probiotic VSL3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 VSL3 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 VSL3 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 VSL3 or placebo in combination with vedolizumab VDZ for six weeks
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 VSL3 or placebo in combination with vedolizumab VDZ for six weeks
Detailed Description:
This study enrolled patients aged 18-85 years with moderate ulcerative colitis and randomly assigned them in a 11 ratio to an experimental group and a control group Patients in the experimental group received two packets of VSL3 450 billion CFUpacket daily for 14 weeks along with Vedolizumab 300 mg once weekly at weeks 0 2 6 and 14 The control group received placebo packets and Vedolizumab on the same schedule The primary outcome was the proportion of patients with a decrease of 3 points in the SCCAI score at week 6 along with improvement in fecal calprotectin FC levels decrease of 50 from baseline at weeks 6 and 14 Secondary outcomes included clinical response clinical remission corticosteroid-free clinical remission and changes in quality of life scores at week 14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None