Adding Bacillus subtilis to infliximab treatment for 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
This study will test whether taking a daily Bacillus subtilis capsule helps adults with active Crohn's disease who are receiving infliximab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | Infliximab |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT07123207 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 with clinically active Crohn's disease (CDAI ≥150 or SES‑CD ≥3) who are currently treated with infliximab and meet standard liver and renal function criteria are ideal candidates.
Not a fit: Patients with significant liver or kidney impairment, active severe infections, intestinal tuberculosis or other chronic intestinal infections, or those not on infliximab are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, adding Bacillus subtilis could boost infliximab's effectiveness and reduce Crohn's disease activity for some patients.
How similar studies have performed: Probiotics in inflammatory bowel disease have produced mixed results and the specific use of Bacillus subtilis alongside infliximab has limited prior evidence, so this combination is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Changsha, Hunan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.