Irritable Bowel Syndrome Clinical Trial
Official title:
Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Verified date | March 2016 |
Source | Nanjing PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: National Natural Science Foundation |
Study type | Interventional |
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome
Status | Completed |
Enrollment | 114 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - All patients(age?18y) - Admitted for diarrhea-predominant irritable bowel syndrome Exclusion Criteria: - Mental disorders - Cancer - Inflammatory bowel disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nanjing PLA General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy: change of stool frequency, faecal form and clinical symptoms score | change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks | six weeks after inclusion | Yes |
Secondary | efficacy: gut microbiota | real-time PCR | six weeks after inclusion | Yes |
Secondary | efficacy: cytokine ratios | Cytokine production | six weeks after inclusion | Yes |
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