Mild to Severe Crohns DiseaseNCT07123207
Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease
A study testing Bacillus subtilis Capsules in people with Mild to Severe Crohns Disease, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild to Severe Crohns Disease
- What is being tested?
- Bacillus subtilis Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Xiaoyan Wang, MD, +8613974889301, wangxiaoyan@csu.edu.cn
Jie Hong, PHD, +8613585691936, jiehong97@sjtu.edu.cn
About this study
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
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.
Read the 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
- Being tested
- Bacillus subtilis Capsules
- Keywords
- Infliximab, Bacillus subtilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus subtilis CapsulesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Bacillus subtilis supplementation group | Experimental | 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. Receives: Dietary Supplement: Bacillus subtilis Capsules |
| control group | No intervention | The control group did not receive additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic remission rate
Endoscopic remission is defined using the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score ranges from 0 to 60, where lower scores indicate less severe disease activity and higher scores indicate more severe disease activity. Endoscopic remission was defined as an SES-CD score ≤2
Measured: 12 weeks
Clinical remission rate
Clinical remission is defined using the Crohn's Disease Activity Index (CDAI). The CDAI score ranges from 0 to approximately 600, where lower scores indicate less severe disease activity and higher scores indicate more severe disease activity. Clinical remission was defined as a CDAI score ≤150.
Measured: 12 weeks
Secondary outcomes (1)
Biomarker target attainment rate
The target of inflammatory biomarkers is defined using the following scales:
- C-Reactive Protein (CRP): CRP levels less than 5 mg/L. The CRP scale ranges from 0 to >100 mg/L, with higher scores indicating higher levels of inflammation.
- Erythrocyte Sedimentation Rate (ESR): ESR levels less than 15 mm/hr for men and less than 20 mm/hr for women. The ESR scale ranges from 0 to >100 mm/hr, with higher scores indicating higher levels of inflammation.
- Fecal Calprotectin (FC): FC levels decreased to 100-250 µg/g. The FC scale ranges from 0 to >500 µg/g, with higher scores indicating higher levels of intestinal inflammation.
The biomarker target attainment rate is the percentage of patients who meet all three criteria at the end of the 12-week period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start4 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Severe Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaoyan Wang, MD, Principal investigator, The Third Xiangya Hospital of Central South UniversityJie Hong, PHD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123207
- Sponsor's protocol ID
- 2025-IFX-BS-XY3
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2025-IFX-BS-XY3
- Conditions
- Mild to Severe Crohns Disease
- Keywords
- Infliximab, Bacillus subtilis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacillus subtilis supplementation group | Experimental | Dietary Supplement: Bacillus subtilis CapsulesPatients 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. |
| control group | No intervention | –The control group did not receive additional intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus subtilis CapsulesBacillus 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. | Dietary supplement | Bacillus subtilis supplementation group |
Primary outcome
Endoscopic remission rate
Time frame: 12 weeks
Endoscopic remission is defined using the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score ranges from 0 to 60, where lower scores indicate less severe disease activity and higher scores indicate more severe disease activity. Endoscopic remission was defined as an SES-CD score ≤2
Clinical remission rate
Time frame: 12 weeks
Clinical remission is defined using the Crohn's Disease Activity Index (CDAI). The CDAI score ranges from 0 to approximately 600, where lower scores indicate less severe disease activity and higher scores indicate more severe disease activity. Clinical remission was defined as a CDAI score ≤150.
1 secondary outcome
Biomarker target attainment rate
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyan Wang, MD principal investigator
The Third Xiangya Hospital of Central South University
Jie Hong, PHD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus subtilis Capsules in people with Mild to Severe Crohns Disease, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Wang, MD (+8613974889301, wangxiaoyan@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic remission rate (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.