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History of Changes for Study: NCT02270268
Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
Latest version (submitted March 23, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 17, 2014 None (earliest Version on record)
2 March 23, 2016 Arms and Interventions and Study Status
Comparison Format:

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Study NCT02270268
Submitted Date:  October 17, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2011NLY073
Brief Title: Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
Official Title: Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2014
Overall Status: Completed
Study Start: November 2011
Primary Completion: October 2013 [Actual]
Study Completion: October 2013 [Actual]
First Submitted: October 10, 2014
First Submitted that
Met QC Criteria:
October 17, 2014
First Posted: October 21, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 17, 2014
Last Update Posted: October 21, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Nanjing PLA General Hospital
Responsible Party: Principal Investigator
Investigator: Gao Tao
Official Title: Nanjing PLA General Hospital
Affiliation: Nanjing PLA General Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief 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
Detailed 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.
Open or close this module Conditions
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Gut microbiota
Soluble dietary fiber
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 114 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: pectin
a kind of soluble dietary fiber
Dietary Supplement: Pectin
Pectin (Andeli Ltd. Yantai, China), 24g/d for six weeks
Placebo Comparator: Placebo
maltodextrin
Open or close this module Outcome Measures
Primary Outcome Measures:
1. efficacy: change of stool frequency, faecal form and clinical symptoms score
[ Time Frame: six weeks after inclusion ]

change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks
Secondary Outcome Measures:
1. efficacy: gut microbiota
[ Time Frame: six weeks after inclusion ]

real-time PCR
2. efficacy: cytokine ratios
[ Time Frame: six weeks after inclusion ]

Cytokine production
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • All patients(age≧18y)
  • Admitted for diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease
Open or close this module Contacts/Locations
Study Officials: Tao Gao, M.D.
Principal Investigator
Nanjing PLA General Hospital
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
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Citations:
Links:
Available IPD/Information:

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