Effects of scFOS on Stool Frequency in People With Functionnal Constipation

NCT ID: NCT01847950

Last Updated: 2018-10-05

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-04-30

Brief Summary

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The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation

Detailed Description

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Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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short-chain fructo-oligosaccharides

Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks

Group Type EXPERIMENTAL

Short-chain fructo-oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks

Maltodextrin

maltodextrins are consummed at 5g/day for 6 weeks

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Short-chain fructo-oligosaccharides

Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* subjects with functional constipation

Exclusion Criteria

* subjects treated with laxative treatments
* subjects consuming more than 25g/day of dietary fibres
* pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syral

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Benamouzig, Pr

Role: PRINCIPAL_INVESTIGATOR

CRNH - CRV Avicenne Hospital

Locations

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CRNH-CRV Avicenne Hospital

Bobigny, , France

Site Status

Countries

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France

Other Identifiers

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ConstiFOS

Identifier Type: -

Identifier Source: org_study_id

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