Effect of Bifidobacterium on intestinal microinflammation and irritable bowel syndrome-like symptoms
- Conditions
- Crohn's disease
- Registration Number
- JPRN-jRCTs031200327
- Lead Sponsor
- Fukui Hirokazu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
Subjects who meet all of the following criteria are included in this study;
1. Subjects who had participated in the previous study (Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom. / UMIN-CTR No. UMIN000041577)
2. Subjects who were sufferred by abdominal pain or discomfort continuously (three days or more within a month), and who show at least two of the following characteristics.
1) these symptoms were attenuated by defecation
2) defecation frequency was changed accompanied with these symptoms (increased or decreased)
3) fecal properties were changed accompanied with these symptoms (became soft or hard)
3. Patients with CDAI (Crohn's Disease Activity Index) of less than 150
4. Patients with CRP of less than 0.3mg/dL
5. Male and female aged 20 years or older
6. Subjects who give their consent in a written form
Subjects who fall into any of the following criteria are excluded from participating in the study;
1. Subjects who are using any intestinal regulator agents or supplements other than biofermin tablet
2. Subjects with history of myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent
3. Subjects with malignant neoplasm
4. Subjects with history of allergy against Bifidobacterium
5. Subjects with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method