Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease
Not applicable · Testing Bacillus subtilis Capsules · 1 site · The Third Xiangya Hospital of Central South University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Bacillus subtilis Capsules (a dietary supplement) as a possible treatment. Condition(s) listed: Mild to Severe Crohns Disease.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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;
Plus 2 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 24 participants are expected to take part.
- Start date: 2025-08-04.
- Main results expected around 2026-09-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Endoscopic remission rate (12 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Mild to Severe Crohns Disease |
| Lead sponsor | The Third Xiangya Hospital of Central South University |
| Collaborators | RenJi Hospital |
| Enrollment | 24 (estimated) |
| Start date | 2025-08-04 |
| Primary completion (est.) | 2026-09-01 |
| First posted | 2025-08-14 |
| Last updated | 2025-08-14 |
| 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 |
| ClinicalTrials.gov ID | NCT07123207 |
Interventions
- Bacillus subtilis Capsules (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 subtil…
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha, Hunan | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.