Adding Bacillus subtilis to infliximab treatment for Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with active Crohn's disease who are already receiving infliximab are randomized to take oral Bacillus subtilis capsules (3×10^9 CFU) once daily for 12 weeks or to a control group with no additional intervention. Participants are followed weekly and return after the intervention period for clinical and endoscopic evaluations, using CDAI and SES‑CD among other indicators. The trial compares whether probiotic supplementation improves infliximab efficacy and disease activity measures. Safety monitoring includes routine liver and kidney function tests and exclusion of participants with severe infections or organ dysfunction.

Why it matters

Who can join: the full rules

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 active infections in the intestines or other areas that require the use of antibiotics or antiviral drugs;
4. Patients with intestinal tuberculosis, other chronic intestinal infectious diseases, and intestinal malignant tumors;
5. Pregnant and lactating women;
6. The fasting blood glucose of patients with diabetes or screening period exceeds 7.0mmol/L or glycosylated hemoglobin exceeds 6.5%;
7. Merge patients with severe mental illness, drug use, alcohol abuse, etc. who are unable to cooperate with the study;
8. Have participated in any other clinical research within the first month prior to enrollment;
9. The researcher determined that any other disease or condition is not suitable for patients participating in this study.

Where it's running

• The Third Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Xiaoyan Wang, MD — The Third Xiangya Hospital of Central South University
• Study coordinator: Xiaoyan Wang, MD
• Email: wangxiaoyan@csu.edu.cn
• Phone: +8613974889301

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.