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

NCT06612411 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: No.2023DZKY-023-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Irritable Bowel Syndrome with Diarrhea; Purine Metabolism Disorder

Outcome Measures

Primary Outcomes (1)

• The score of IBS-SSS before and after intervention

  6 months

Secondary Outcomes (1)

• The concentration of purine in the stool before and after intervention

  6 months

Study Arms (2)

B. subtilis intervention

ACTIVE COMPARATOR

Drug: B. subtilis

Placebo capsules

PLACEBO COMPARATOR

Drug: Dead B. subtilis

Interventions

B. subtilis DRUG

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

Also known as: Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd

B. subtilis intervention

Dead B. subtilis DRUG

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

Also known as: Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd

Placebo capsules

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (2)

Jinling Hospital

Nanjing, China

RECRUITING

Jinling Hospital

Nanjing, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: September 25, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)