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NCT02270268 Clinical Trial

Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02270268
Other study ID # 2011NLY073
Secondary ID
Status Completed
Phase Phase 3
First received October 10, 2014
Last updated March 23, 2016
Start date November 2011
Est. completion date October 2013

Study information
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

Clinical Trial Summary

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

Description:

Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the clinical symptoms, gut microbiota and the immune markers in two groups.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Pectin
Pectin (Andeli Ltd. Yantai, China), 24g/d for six weeks
• maltodextrin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nanjing PLA General Hospital

Outcome
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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