Actively Recruiting
The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-09-24
100
Participants Needed
12
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years
- Diagnosed with ulcerative colitis at least 90 days before baseline, confirmed by recent colonoscopy and pathology reports
- Moderate active ulcerative colitis with a Mayo score of 6-10 at screening
- Planned treatment with Vedolizumab as initial therapy or reinduction (no Vedolizumab in past year)
- Demonstrated inadequate response, loss of response, or intolerance to oral aminosalicylates or immunosuppressants
- Stable dose of oral 5-ASA and immunosuppressants for at least 2 weeks before screening
- Willing and able to comply with study restrictions and complete study diaries and visits
You will not qualify if you...
- Diagnosis of Crohn's disease, undetermined inflammatory bowel disease, or other colitis
- Ulcerative colitis limited to the rectum (less than 15 cm from anal verge)
- Started steroid therapy within 2 weeks before screening
- Used antibiotics within 2 weeks before screening
- Used other probiotics within 2 weeks before study entry
- Used rectal 5-ASA within 1 week before study entry
- Changed oral 5-ASA or immunosuppressant doses after colonoscopy screening
- Taken NSAIDs or anti-diarrheal drugs for 5 consecutive days within 1 week before screening
- Positive Clostridioides difficile toxin test within 1 month before screening
- Pregnant or breastfeeding women
- Use of other biologics or advanced therapies currently or previously
- Allergy to maltose, cornstarch, or silica
- Severe heart, liver, lung, kidney, hematologic, or serious diseases affecting survival, such as cancer, AIDS, asthma, kidney dysfunction, abnormal blood counts or liver/kidney tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
The Seventh Medical Center, PLA General Hospital
Beijing, Beijing Municipality, China, 100000
Not Yet Recruiting
2
Chongqing General Hospital
Chongqing, Chongqing Municipality, China, 401147
Actively Recruiting
3
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Not Yet Recruiting
4
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Actively Recruiting
5
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710004
Not Yet Recruiting
6
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
7
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
8
2nd Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
9
Huzhou City Central Hospital
Huzhou, Zhejiang, China, 313000
Not Yet Recruiting
10
Jinhua City Central Hospital
Jinhua, Zhejiang, China, 321000
Not Yet Recruiting
11
Quzhou City People's Hospital
Quzhou, Zhejiang, China, 324000
Not Yet Recruiting
12
The Second Affiliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
Y
Yan Chen, PhD
CONTACT
Q
Qiao Yu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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