NCT07123207Recruiting
Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With 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
Source: ClinicalTrials.gov · Last updated 14 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- 4 Aug 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Diseases
- Crohn's disease
- NCT number
- NCT07123207
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 4 Aug 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have participated in any other clinical research within the first month prior to enrollment;
Other illness
- Patients with severe active infections in the intestines or other areas that require the use of antibiotics or antiviral drugs;
- Patients with intestinal tuberculosis, other chronic intestinal infectious diseases, and intestinal malignant tumors;
- Merge patients with severe mental illness, drug use, alcohol abuse, etc. who are unable to cooperate with the study;
- The researcher determined that any other disease or condition is not suitable for patients participating in this study.
Lab values
- 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;
- Patients with creatinine clearance rate less than 60ml/min;
- The fasting blood glucose of patients with diabetes or screening period exceeds 7.0mmol/L or glycosylated hemoglobin exceeds 6.5%;
Other
- Participants who meet any of the following criteria are not eligible for inclusion in this study.
- Pregnant and lactating women;
Who the study is looking for
- Age ≥ 18 years old, ≤ 75 years old;
- 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;
- Patients receiving treatment with Infliximab;
- The patient is currently in the clinical active stage(CDAI≥150 or SES-CD≥3);
- Agree to participate in this study and sign an informed consent form.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.