Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease

NCT ID: NCT07123207

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-04
• Study Completion Date: 2027-01-30

Brief Summary

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.

Detailed Description

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.

Conditions

Mild to Severe Crohns Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bacillus subtilis supplementation 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.

Group Type: EXPERIMENTAL

Bacillus subtilis Capsules

Intervention Type: DIETARY_SUPPLEMENT

Bacillus subtilis is a type of probiotic. Studies have found that supplementation with Bacillus subtilis can effectively maintain the remission of inflammatory bowel disease by protecting intestinal integrity, regulating epithelial proliferation, and reshaping the structure and function of the microbiota.

Bacillus subtilis capsules are a Bacillus supplement containing 3×10⁹ CFU of Bacillus subtilis per capsule. Patients in the Bacillus subtilis supplementation group take Bacillus subtilis capsules orally once a day, one capsule each time, for 12 weeks.

control group

The control group did not receive additional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bacillus subtilis Capsules

Bacillus subtilis is a type of probiotic. Studies have found that supplementation with Bacillus subtilis can effectively maintain the remission of inflammatory bowel disease by protecting intestinal integrity, regulating epithelial proliferation, and reshaping the structure and function of the microbiota.

Bacillus subtilis capsules are a Bacillus supplement containing 3×10⁹ CFU of Bacillus subtilis per capsule. Patients in the Bacillus subtilis supplementation group take Bacillus subtilis capsules orally once a day, one capsule each time, for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Jie Hong, PHD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Wang, MD

Role: CONTACT

wangxiaoyan@csu.edu.cn

+8613974889301

Jie Hong, PHD

Role: CONTACT

jiehong97@sjtu.edu.cn

+8613585691936

Facility Contacts

Xiaoyan Wang, MD

Role: primary

wangxiaoyan@csu.edu.cn

+8613974889301

Jie Hong, PHD

Role: backup

jiehong97@sjtu.edu.cn

+8613585691936

Other Identifiers

2025-IFX-BS-XY3

Identifier Type: -

Identifier Source: org_study_id