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

Jinling Hospital, China

Status and phase: Enrolling; Early Phase 1

Conditions: Irritable Bowel Syndrome with Diarrhea; Purine Metabolism Disorder

Treatments: Drug: Dead B. subtilis; Drug: B. subtilis

Study type: Interventional

Funder types: Other

Identifiers

NCT06612411

No.2023DZKY-023-01

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

B. subtilis intervention

Active Comparator group

Treatment:

Drug: B. subtilis

Placebo capsules

Placebo Comparator group

Treatment:

Drug: Dead B. subtilis