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Recruiting NCT07123207

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

No phase Interventional Mild to Severe Crohns Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bacillus subtilis Capsules.
Who it may be relevant to
Registry conditions: Mild to Severe Crohns Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Dietary supplement 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 capsu

Primary outcome measures

  • Endoscopic remission rate [Time frame: 12 weeks]
  • Clinical remission rate [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Biomarker target attainment rate [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

Participants who meet any of the following criteria are not eligible for inclusion in this study.

  • 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;
  • 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;
  • Pregnant and lactating women;
  • The fasting blood glucose of patients with diabetes or screening period exceeds 7.0mmol/L or glycosylated hemoglobin exceeds 6.5%;
  • Merge patients with severe mental illness, drug use, alcohol abuse, etc. who are unable to cooperate with the study;
  • Have participated in any other clinical research within the first month prior to enrollment;
  • The researcher determined that any other disease or condition is not suitable for patients participating in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Third Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT07123207 · 2025-IFX-BS-XY3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗