Irritable Bowel Syndrome
Conditions
Keywords
stress, brain-gut interactions, visceral perception, gastrointestinal motility, emotion
Brief summary
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients.
Detailed description
There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients. IBS patients will be enrolled via advertisement. Any IBS subtypes will not be rejected. They will take either 1.0 g of Bifidobacterium breve 3 times a day or same amount of placebo for 8 weeks. IBS symptoms and allied markers will be checked before, during, and after the administration.
Interventions
1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks.
DRUGPlacebo
1.0 g of placebo, taking orally, 3 times a day for 8 weeks.
Sponsors
Tohoku University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of IBS with Rome II definition
Exclusion criteria
* Diagnosis of serious diseases (both physically and mentally)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate relief and SIBSQ | 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Psychometric test, bowel gas, blood, and feces. | 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment |
Countries
Japan
Contacts
Primary ContactShin Fukudo, MD, PhD
Backup ContactMachiko Watabe
Outcome results
None listed