Effect of Bifidobacterium on Irritable Bowel Syndrome
Effect of Bifidobacterium on Irritable Bowel Syndrome
| Sponsors |
Lead Sponsor: Tohoku University |
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| Source | Tohoku University | ||||||
| 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. |
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| 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. |
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| Overall Status | Unknown status | ||||||
| Start Date | January 2006 | ||||||
| Completion Date | September 2008 | ||||||
| Primary Completion Date | August 2008 | ||||||
| Phase | N/A | ||||||
| Study Type | Interventional | ||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 50 | ||||||
| Condition | |||||||
| Intervention |
Intervention Type: Drug Intervention Name: Bifidobacterium breve Description: 1.0 g of Bifidobacterium breve, taking orally, 3 times a day for 8 weeks. Arm Group Label: A Intervention Type: Drug Intervention Name: Placebo Description: 1.0 g of placebo, taking orally, 3 times a day for 8 weeks. Arm Group Label: B |
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| Eligibility |
Criteria:
Inclusion Criteria: - Diagnosis of IBS with Rome II definition Exclusion Criteria: - Diagnosis of serious diseases (both physically and mentally) Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Overall Official |
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| Overall Contact |
Last Name: Shin Fukudo, MD, PhD Phone: +81-22-717-8214 Email: [email protected] |
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| Location |
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| Location Countries |
Japan |
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| Verification Date |
August 2008 |
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| Responsible Party |
Name Title: Shin Fukudo Organization: Tohoku University Graduate School of Medicine |
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| Has Expanded Access | No | ||||||
| Condition Browse | |||||||
| Number Of Arms | 2 | ||||||
| Arm Group |
Label: A Type: Experimental Description: Bifidobacterium breve Label: B Type: Placebo Comparator Description: Placebo |
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| Acronym | PBIBS | ||||||
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Basic Science Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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