NCT06612411

B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis

Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial.

Conditions

• Irritable Bowel Syndrome with Diarrhea
• Purine Metabolism Disorder

Interventions

Type	Name	Description
DRUG	B. subtilis	2 capsules, 3 times a day, orally taken for one month
DRUG	Dead B. subtilis	2 capsules, 3 times a day, orally taken for one month

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-09-25
• Last updated: 2024-09-25

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study