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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Treatment Benefits of Probiotic Clostridium Butyricum CBM588® for IBS-D

NCT06676514

IBS-D (Diarrhea-predominant)

COMPLETED NA

Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

NCT02614963

Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

UNKNOWN PHASE4

The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients

NCT02254629

Irritable Bowel Syndrome

COMPLETED PHASE1

A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D

NCT06247046

Irritable Bowel Syndrome With Diarrhea

RECRUITING PHASE3

Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D

NCT04074421

IBS - Irritable Bowel Syndrome Gut Microbiota

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome with Diarrhea Purine Metabolism Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

B. subtilis intervention

Group Type ACTIVE_COMPARATOR

B. subtilis

Intervention Type DRUG

2 capsules, 3 times a day, orally taken for one month

Placebo capsules

Group Type PLACEBO_COMPARATOR

Dead B. subtilis

Intervention Type DRUG

2 capsules, 3 times a day, orally taken for one month

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

B. subtilis

2 capsules, 3 times a day, orally taken for one month

Intervention Type DRUG

Dead B. subtilis

2 capsules, 3 times a day, orally taken for one month

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes