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Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome

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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

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Pectin Dietary Supplement: maltodextrin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study Start Date : November 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Pectin

Arm Intervention/treatment
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
Dietary Supplement: maltodextrin



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270268


Sponsors and Collaborators
Nanjing PLA General Hospital
Investigators
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Principal Investigator: Tao Gao, M.D. Nanjing PLA General Hospital
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Responsible Party: Gao Tao, Nanjing PLA General Hospital
ClinicalTrials.gov Identifier: NCT02270268    
Other Study ID Numbers: 2011NLY073
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Keywords provided by Gao Tao, Nanjing PLA General Hospital:
Irritable bowel syndrome
Gut microbiota
Soluble dietary fiber
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases