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

NCT06612411 · tracked via the Priya Life Science China tracker

Sponsor

Jinling Hospital, China

Phase

Phase EARLY_PHASE1

Started

2024-06-01

Last updated

2024-09-25

Condition(s) studied

Irritable Bowel Syndrome with DiarrheaPurine Metabolism Disorder

Investigational drug(s) / intervention(s)

B. subtilisDead B. subtilis

B. subtilis: 2 capsules, 3 times a day, orally taken for one month

Dead B. subtilis: 2 capsules, 3 times a day, orally taken for one month

Study 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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

80 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

The score of IBS-SSS before and after intervention — 6 months

Trial sites (2)

Facility	City	Region	Status
Jinling Hospital	Nanjing	China	Recruiting
Jinling Hospital	Nanjing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06612411 on ClinicalTrials.gov ↗ ← All trials in China