RecruitingNot ApplicableNCT07123207

Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease

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

Sponsor

The Third Xiangya Hospital of Central South University

Enrollment

24 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

Mild to Severe Crohns Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether adding a probiotic (Bacillus subtilis) to infliximab treatment helps improve outcomes for people with Crohn's disease, a type of inflammatory bowel disease. **You may be eligible if...** - You are 18–75 years old - You have a confirmed diagnosis of Crohn's disease - You are currently being treated with infliximab (a biologic medication) - Your disease activity meets certain clinical criteria based on standard scoring **You may NOT be eligible if...** - You have a serious infection, including tuberculosis or hepatitis B or C - You have had major surgery in the past 3 months or are planning surgery soon - You are pregnant or breastfeeding - You have other serious conditions such as heart failure, cancer, or severe kidney or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTBacillus 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

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NCT07123207

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