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Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease
Sponsor: The Third Xiangya Hospital of Central South University
Summary
The goal of this clinical trial is to evaluate the effect of supplementing Bacillus subtilis compared to the control group on the efficacy of Infliximab in patients with Crohn's disease, and to summarize the role of supplementing Bacillus subtilis in the treatment of CD patients. Participants will be randomized into two groups: the Bacillus subtilis supplementation group and the control group. The patients in the Bacillus subtilis supplementation group received oral Bacillus subtilis capsules for 12 weeks. The control group did not receive additional intervention. Follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.
Official title: The Impact of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease: a Multicenter, Randomized, Single-blind, Blank-controlled Clinical Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-08-04
Completion Date
2027-01-30
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
Bacillus subtilis Capsules
Bacillus subtilis is a type of probiotic. Studies have found that supplementation with Bacillus subtilis can effectively maintain the remission of inflammatory bowel disease by protecting intestinal integrity, regulating epithelial proliferation, and reshaping the structure and function of the microbiota. Bacillus subtilis capsules are a Bacillus supplement containing 3×10⁹ CFU of Bacillus subtilis per capsule. Patients in the Bacillus subtilis supplementation group take Bacillus subtilis capsules orally once a day, one capsule each time, for 12 weeks.
Locations (1)
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China