Effect of scFOS on Increase in Stool Frequency in Constipated People

Not Applicable

Completed

• Conditions: Healthy; Functional Constipation
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: scFOS

• Registration Number: NCT03707002
• Lead Sponsor: Syral

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.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-10
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-15
• Last Update Submitted: 2018-10-15
• Study First Posted: 2018-10-16
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Maltodextrin	maltodextrin consumed at 5g/day for 6 weeks
scFOS	scFOS	scFOS consumed at 5g/day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Stool frequency	6 weeks	Change in the number of stool per week between week at Baseline and the last week of supplementation

Secondary Outcome Measures

Name	Time	Method
Anxiety and depression	6 weeks	Changes in anxiety and depression score between Baseline and the end of supplementation, measured by HAD score (Zigmond et al, 1983, from 0 to 21, score above 11 = anxiety or depression related pathology
Frequency and severity of Gastrointestinal symptoms	6 weeks	Change in the frequency (number of occurrence) and severity (Likert scores from 0= no symptom to 7 =severe symptoms) individual Gastro-Intestinal symptoms (bloating, abdominal pain, flatulence,...) between Baseline and the end of supplementation
Stool consistency	6 weeks	Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)

Trial Locations

Locations (1)

Biofortis SAS; 🇫🇷 Saint-Herblain, France