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Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02270268
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Gao Tao, Nanjing PLA General Hospital

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE October 21, 2014
Last Update Posted Date March 24, 2016
Study Start Date  ICMJE November 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
  • efficacy: gut microbiota [ Time Frame: six weeks after inclusion ]
    real-time PCR
  • efficacy: cytokine ratios [ Time Frame: six weeks after inclusion ]
    Cytokine production
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
Official Title  ICMJE Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Dietary Supplement: Pectin
    Pectin (Andeli Ltd. Yantai, China), 24g/d for six weeks
  • Dietary Supplement: maltodextrin
Study Arms  ICMJE
  • Experimental: pectin
    a kind of soluble dietary fiber
    Intervention: Dietary Supplement: Pectin
  • Placebo Comparator: Placebo
    maltodextrin
    Intervention: Dietary Supplement: maltodextrin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2014)
114
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental disorders
  • Cancer
  • Inflammatory bowel disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02270268
Other Study ID Numbers  ICMJE 2011NLY073
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gao Tao, Nanjing PLA General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nanjing PLA General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tao Gao, M.D. Nanjing PLA General Hospital
PRS Account Nanjing PLA General Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP