Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Inflixima
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 tw
| Condition(s) | Mild to Severe Crohns Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years old, ≤ 75 years old; 2. 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; 3. Patients receiving treatment with Infliximab; 4. The patient is currently in the clinical active stage(CDAI≥150 or SES-CD≥3); 5. Agree to participate in this study and sign an informed consent form. Exclusion Criteria: Participants who meet any of the following criteria are not eligible for inclusion in this study. 1. Patients with ALT or AST exceeding the normal upper limit by more than twice, and TBIL exceeding the normal upper limit by more than twice; 2. Patients with creatinine clearance rate less than 60ml/min; 3. Patients with severe activ |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | The Third Xiangya Hospital of Central South University |
| Locations | Changsha, Hunan, China |
| Start date | 2025-08-04 |
| NCT ID | NCT07123207 |
| Official listing | https://clinicaltrials.gov/study/NCT07123207 |