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.
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);
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;
Patients with creatinine clearance rate less than 60ml/min;
Patients with severe active infections in the intestines or other areas that require the use of antibiotics or antiviral drugs;
Patients with intestinal tuberculosis, other chronic intestinal infectious diseases, and intestinal malignant tumors;
The Third Xiangya Hospital of Central South University
Lead sponsor
RenJi Hospital
Collaborator