Actively Recruiting
Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease
Led by The Third Xiangya Hospital of Central South University · Updated on 2025-08-14
24
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
T
The Third Xiangya Hospital of Central South University
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Clinically diagnosed with Crohn's disease according to Chinese Guidelines for Diagnosis and Treatment (Guangzhou, 2023)
- Currently receiving treatment with Infliximab
- Currently in active clinical stage with CDAI 65150 or SES-CD 653
- Agree to participate and sign informed consent
You will not qualify if you...
- ALT or AST levels more than twice the normal upper limit and TBIL more than twice the normal upper limit
- Creatinine clearance rate less than 60 ml/min
- Severe active infections requiring antibiotics or antiviral drugs
- Intestinal tuberculosis, other chronic intestinal infections, or intestinal malignant tumors
- Pregnant or lactating women
- Diabetes with fasting blood glucose over 7.0 mmol/L or glycosylated hemoglobin over 6.5%
- Severe mental illness, drug use, or alcohol abuse preventing cooperation
- Participation in any other clinical research within 1 month prior to enrollment
- Any other disease or condition deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
X
Xiaoyan Wang, MD
CONTACT
J
Jie Hong, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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