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

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 21, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Ulcerative Colitis
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.

Trial Locations (12)

100000

NOT_YET_RECRUITING

The Seventh Medical Center, PLA General Hospital, Beijing

310006

RECRUITING

Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou

310009

NOT_YET_RECRUITING

2nd Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

313000

NOT_YET_RECRUITING

Huzhou City Central Hospital, Huzhou

321000

NOT_YET_RECRUITING

Jinhua City Central Hospital, Jinhua

324000

NOT_YET_RECRUITING

Quzhou City People's Hospital, Quzhou

325000

NOT_YET_RECRUITING

The Second Affiliated Hospital, Wenzhou Medical University, Wenzhou

401147

RECRUITING

Chongqing General Hospital, Chongqing

430060

RECRUITING

Renmin Hospital of Wuhan University, Wuhan

510655

NOT_YET_RECRUITING

The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou

610041

NOT_YET_RECRUITING

West China Hospital of Sichuan University, Chengdu

710004

NOT_YET_RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER