Back to resultsEffects of scFOS on Stool Frequency in People With Functionnal Constipation
Primary Purpose
Functional Constipation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Short-chain fructo-oligosaccharides
Maltodextrin
Sponsored by
About this trial
This is an interventional other trial for Functional Constipation
Eligibility Criteria
Inclusion Criteria:
- subjects with functional constipation
Exclusion Criteria:
- subjects treated with laxative treatments
- subjects consuming more than 25g/day of dietary fibres
- pregnant women
Sites / Locations
- CRNH-CRV Avicenne Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
short-chain fructo-oligosaccharides
Maltodextrin
Arm Description
Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks
maltodextrins are consummed at 5g/day for 6 weeks
Outcomes
Primary Outcome Measures
Frequency of stool emission
Secondary Outcome Measures
Stool consistency (Bristol scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847950
Brief Title
Effects of scFOS on Stool Frequency in People With Functionnal Constipation
Official Title
Randomized, Placebo-controlled Double-blind Study to Evaluate the Effects of Fructo-oligosachharides on Increase of Stool Frequency in Constipated People
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syral
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
short-chain fructo-oligosaccharides
Arm Type
Experimental
Arm Description
Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
maltodextrins are consummed at 5g/day for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Short-chain fructo-oligosaccharides
Intervention Description
Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Primary Outcome Measure Information:
Title
Frequency of stool emission
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Stool consistency (Bristol scale)
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Transit time
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
subjects with functional constipation
Exclusion Criteria:
subjects treated with laxative treatments
subjects consuming more than 25g/day of dietary fibres
pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Benamouzig, Pr
Organizational Affiliation
CRNH - CRV Avicenne Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRNH-CRV Avicenne Hospital
City
Bobigny
ZIP/Postal Code
93009
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effects of scFOS on Stool Frequency in People With Functionnal Constipation
We'll reach out to this number within 24 hrs