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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Functional Constipation
• Intervention / Treatment: Dietary supplement: scFOS; Dietary supplement: Maltodextrin

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 Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Herblain, France, 44800
    • Biofortis Sas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: scFOS; scFOS consumed at 5g/day for 6 weeks	Dietary supplement: scFOS; daily intake for 6 weeks
Placebo Comparator: Placebo; maltodextrin consumed at 5g/day for 6 weeks	Dietary supplement: Maltodextrin; daily intake for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency	Change in the number of stool per week between week at Baseline and the last week of supplementation	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool consistency	Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)	6 weeks
Frequency and severity of Gastrointestinal symptoms	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	6 weeks
Anxiety and depression	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	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	heart rate (bit per minute)	at baseline and at the last visit (after 6 weeks)
systolic blood pressure	systolic blood pressure (mmHg)	at baseline and at the last visit (after 6 weeks)
diastolic blood pressure	diastolic blood pressure (mmHg)	at baseline and at the last visit (after 6 weeks)
Adverse event	Registration of all adverse events (number and severity of events)	6 weeks

Collaborators and Investigators

• Sponsor: Syral
• Collaborators: Biofortis Mérieux NutriSciences; CreaBio Rhone-Alpes
• Investigators: Principal Investigator: David Gendre, MD, Biofortis

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: PEC14513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No