RecruitingRecruiting
Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease
NCT07123207 · The Third Xiangya Hospital of Central South University
In plain English
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Official title
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
About this study
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. Patients in the Bacillus subtilis supplementation group take oral Bacillus subtilis capsules once a day, one capsule per time, for 12 weeks, each containing 3×10⁹ CFU of Bacillus subtilis. 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.
Eligibility 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.
Study design
Enrollment target: 24 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-08-04
Estimated completion: 2027-01-30
Last updated: 2025-08-14
Interventions
Dietary Supplement: Bacillus subtilis Capsules
Primary outcomes
- • Endoscopic remission rate (12 weeks)
- • Clinical remission rate (12 weeks)
Sponsor
The Third Xiangya Hospital of Central South University · other
With: RenJi Hospital
Contacts & investigators
ContactXiaoyan Wang, MD · contact · wangxiaoyan@csu.edu.cn · +8613974889301
ContactJie Hong, PHD · contact · jiehong97@sjtu.edu.cn · +8613585691936
InvestigatorXiaoyan Wang, MD · principal_investigator, The Third Xiangya Hospital of Central South University
InvestigatorJie Hong, PHD · principal_investigator, RenJi Hospital
All locations (1)
The Third Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China