Irritable Bowel Syndrome with Diarrhea, Purine Metabolism Disorder
Conditions
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.
Interventions
DRUGB. subtilis
2 capsules, 3 times a day, orally taken for one month
DRUGDead B. subtilis
2 capsules, 3 times a day, orally taken for one month
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The score of IBS-SSS before and after intervention | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| The concentration of purine in the stool before and after intervention | 6 months |
Countries
China
Outcome results
None listed