Effect of scFOS on Increase in Stool Frequency in Constipated People

NCT ID: NCT03707002

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Functional Constipation Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Identical sachets containing 5g of scFOS or placebo (maltodextrins)

Study Groups

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scFOS

scFOS consumed at 5g/day for 6 weeks

Group Type ACTIVE_COMPARATOR

scFOS

Intervention Type DIETARY_SUPPLEMENT

daily intake for 6 weeks

Placebo

maltodextrin consumed at 5g/day for 6 weeks

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

daily intake for 6 weeks

Interventions

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scFOS

daily intake for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

daily intake for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biofortis Mérieux NutriSciences

OTHER

Sponsor Role collaborator

CreaBio Rhone-Alpes

UNKNOWN

Sponsor Role collaborator

Syral

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Gendre, MD

Role: PRINCIPAL_INVESTIGATOR

BioFortis

Locations

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Biofortis SAS

Saint-Herblain, , France

Site Status

Countries

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France

Other Identifiers

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PEC14513

Identifier Type: -

Identifier Source: org_study_id

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