Effect of scFOS on Increase in Stool Frequency in Constipated People
CONSYST
Randomized, Placebo-controlled Double Blind Study to Evaluate the Effects of Dietary Supplementation With Short-chain Fructo-oligosaccharides (scFOS) on Nincrease in Stool Frequency in Constipated People
1 other identifier
interventional
186
1 country
1
Brief Summary
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 16, 2018
CompletedOctober 16, 2018
October 1, 2018
1.3 years
October 5, 2018
October 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Stool frequency
Change in the number of stool per week between week at Baseline and the last week of supplementation
6 weeks
Secondary Outcomes (3)
Stool consistency
6 weeks
Frequency and severity of Gastrointestinal symptoms
6 weeks
Anxiety and depression
6 weeks
Other Outcomes (4)
Heart rate
at baseline and at the last visit (after 6 weeks)
systolic blood pressure
at baseline and at the last visit (after 6 weeks)
diastolic blood pressure
at baseline and at the last visit (after 6 weeks)
- +1 more other outcomes
Study Arms (2)
scFOS
ACTIVE COMPARATORscFOS consumed at 5g/day for 6 weeks
Placebo
PLACEBO COMPARATORmaltodextrin consumed at 5g/day for 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- functional constipation according to ROME III criteria with 3 or less than 3 stools per week
- BMI between 18 and 32kg/m², limits included
- Subjects who do not usually eat high-fibre foods
- Subjects who do not usually consume foods siad "reduced in sugars" or "light"
- Subjects who do not consume regularly pre- and probiotics in the form of dietary supplements
You may not qualify if:
- subjects presenting Irritable bowel syndrome
- history of chronic GI disorders: crohn disease, ulcerative colitis,....
- treatments likely to influence GI sensitivity or motility (laxative, neuroleptics,...)
- Antibiotic therapy in progress or in the past 8 weeks
- medical history with impact on the study objectives as defined by investigator
- known food allergy to one of the compounds of the study product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syrallead
- Biofortis Mérieux NutriSciencescollaborator
- CreaBio Rhone-Alpescollaborator
Study Sites (1)
Biofortis SAS
Saint-Herblain, 44800, France
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
David Gendre, MD
BioFortis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Identical sachets containing 5g of scFOS or placebo (maltodextrins)
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2018
First Posted
October 16, 2018
Study Start
October 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
October 16, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share