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

Early Phase 1RecruitingNCT06612411

Jinling Hospital, China180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Irritable Bowel Syndrome with Diarrhea Purine Metabolism Disorder

Interventions

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Jinling Hospital

Nanjing, China

RECRUITING

Jinling Hospital

Nanjing, China

RECRUITING

Outcomes

Primary Outcomes

The score of IBS-SSS before and after intervention

Time frame: 6 months

Secondary Outcomes

The concentration of purine in the stool before and after intervention

Time frame: 6 months