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

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome with Diarrhea, Purine Metabolism Disorder

In brief

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.

Key facts

Study ID

NCT06612411

Run by

Jinling Hospital, China

People needed

180

Starts

2024-06-01

Expected to finish

2024-12-31

Last updated by the study team

2024-09-25

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Jinling Hospital — Nanjing, China (enrolling)
• Jinling Hospital — Nanjing, China (enrolling)

Full record on ClinicalTrials.gov

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