Clinical Effects of Soluble Dietary Fiber Supplementation
August 22, 2018 updated by: Gao Tao, Nanjing PLA General Hospital
Study of Soluble Dietary Fiber on Colonic Transit Time and Clinical Symptoms in Adults With Slow-transit Constipation
The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation.
Study Overview
Detailed Description
Patients were randomized to receive either pectin or placebo.
Treatment consisted of 4 weeks supplementation with pectin (fiber group) or placebo.
We evaluated the colonic transit time, constipation symptoms and fecal bacterial population in two groups.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients(age≧18y)
- Admitted for slow-transit constipation were considered eligible
Exclusion Criteria:
- Mental disorders
- Cancer
- Inflammatory bowel disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: soluble dietary fiber
pectin, a kind of soluble dietary fiber
|
pectin （Andeli Ltd.
Yantai, China）, 24g/d for 4weeks
Other Names:
|
|
NO_INTERVENTION: Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
efficacy: intestinal transit time
Time Frame: four weeks after inclusion
|
colonic transit time
|
four weeks after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
efficacy: clinical symptoms
Time Frame: four weeks after inclusion
|
Wexner constipation score
|
four weeks after inclusion
|
|
efficacy: gut microbiota
Time Frame: four weeks after inclusion
|
real-time PCR
|
four weeks after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (ACTUAL)
October 1, 2012
Study Completion (ACTUAL)
October 1, 2012
Study Registration Dates
First Submitted
July 17, 2014
First Submitted That Met QC Criteria
July 18, 2014
First Posted (ESTIMATE)
July 21, 2014
Study Record Updates
Last Update Posted (ACTUAL)
August 24, 2018
Last Update Submitted That Met QC Criteria
August 22, 2018
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011NLY42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.