Using B. subtilis to reduce symptoms in diarrhea-predominant IBS
Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome
This study is testing if a probiotic called B. subtilis can help people with diarrhea-predominant IBS feel better over four weeks.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 16 Years to 80 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 2 sites (Nanjing and 1 other locations) |
| Trial ID | NCT06612411 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of B. subtilis probiotics in alleviating symptoms in patients with diarrhea-predominant Irritable Bowel Syndrome (IBS-D). Participants aged 16-80 diagnosed with IBS according to the Rome IV criteria will be randomly assigned to receive either B. subtilis or a placebo for four weeks. Clinical symptoms and stool samples will be collected before and after the intervention to assess changes. The study is designed as a single-blind trial, ensuring that researchers are unaware of which treatment participants receive.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16-80 diagnosed with diarrhea-predominant IBS.
Not a fit: Patients with inflammatory bowel diseases, infectious diarrhea, or those currently taking probiotics or medications affecting uric acid levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new probiotic treatment option for patients suffering from IBS-D.
How similar studies have performed: While the specific use of B. subtilis in this context may be novel, similar probiotic interventions have shown promise in managing IBS symptoms in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients are diagnosed with IBS. IBS was diagnosed based on the Rome IV criteria. Subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included. Exclusion Criteria: Subjects who are taking any probiotics, PPIs, antibiotics or any drugs affecting uric acid levels for at least one month before the study. Subjects who decline to participate into the study.
Where this trial is running
Nanjing and 1 other locations
- Jinling Hospital — Nanjing, China (Recruiting)
- Jinling Hospital — Nanjing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.