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

Syral1 site in 1 country186 target enrollmentOctober 2015

ConditionsFunctional Constipation Healthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Functional Constipation
Sponsor: Syral
Enrollment: 186
Locations: 1
Primary Endpoint: Stool frequency
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

This randomized, placebo-controlled, double-blind study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

January 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Syral

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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