Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease
In plain words A study of bacillus subtilis in people 18 to 75, run by The Third Xiangya Hospital of Central South University. It plans to enroll about 24 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Mild to Severe Crohns Disease.
- Age ≥ 18 years old, ≤ 75 years old;
- Patients clinically diagnosed with Crohn's disease shall refer to the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) for diagnostic criteria;
- Patients receiving treatment with Infliximab;
- The patient is currently in the clinical active stage(CDAI≥150 or SES-CD≥3);
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Bacillus subtilis Capsules
Registered 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. The full summary is on the listing.
Where, as registered
No US site; China (1).