NCT07123207

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The Third Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Patients in the Bacillus subtilis supplementation group take oral Bacillus subtilis capsules once a day, one capsule per time, for 12 weeks, each containing 3×10⁹ CFU of Bacillus subtilis. 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.

Conditions

• Mild to Severe Crohns Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-09-01
• Completion: 2027-01-30
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China