B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B. subtilis, Dead B. subtilis.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome with Diarrhea, Purine Metabolism Disorder. Basic parameters: 16 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome
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.
Interventions
- Drug B. subtilis
2 capsules, 3 times a day, orally taken for one month - Drug Dead B. subtilis
2 capsules, 3 times a day, orally taken for one month
Primary outcome measures
- The score of IBS-SSS before and after intervention [Time frame: 6 months]
Secondary outcome measures (1)
- The concentration of purine in the stool before and after intervention [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Jinling Hospital — Nanjing
- Jinling Hospital — Nanjing
Identifiers
NCT: NCT06612411 · No.2023DZKY-023-01