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Effect of scFOS on Increase in Stool Frequency in Constipated People (CONSYST)

Primary Purpose

Functional Constipation, Healthy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
scFOS
Maltodextrin
Sponsored by
Syral
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Functional Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Biofortis SAS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

scFOS

Placebo

Arm Description

scFOS consumed at 5g/day for 6 weeks

maltodextrin consumed at 5g/day for 6 weeks

Outcomes

Primary Outcome Measures

Stool frequency
Change in the number of stool per week between week at Baseline and the last week of supplementation

Secondary Outcome Measures

Stool consistency
Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)
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
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

Full Information

First Posted
October 5, 2018
Last Updated
October 15, 2018
Sponsor
Syral
Collaborators
Biofortis Mérieux NutriSciences, CreaBio Rhone-Alpes
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1. Study Identification

Unique Protocol Identification Number
NCT03707002
Brief Title
Effect of scFOS on Increase in Stool Frequency in Constipated People
Acronym
CONSYST
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syral
Collaborators
Biofortis Mérieux NutriSciences, CreaBio Rhone-Alpes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation, Healthy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Identical sachets containing 5g of scFOS or placebo (maltodextrins)
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
scFOS
Arm Type
Active Comparator
Arm Description
scFOS consumed at 5g/day for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
maltodextrin consumed at 5g/day for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
scFOS
Intervention Description
daily intake for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
daily intake for 6 weeks
Primary Outcome Measure Information:
Title
Stool frequency
Description
Change in the number of stool per week between week at Baseline and the last week of supplementation
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Stool consistency
Description
Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)
Time Frame
6 weeks
Title
Frequency and severity of Gastrointestinal symptoms
Description
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
Time Frame
6 weeks
Title
Anxiety and depression
Description
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
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Heart rate
Description
heart rate (bit per minute)
Time Frame
at baseline and at the last visit (after 6 weeks)
Title
systolic blood pressure
Description
systolic blood pressure (mmHg)
Time Frame
at baseline and at the last visit (after 6 weeks)
Title
diastolic blood pressure
Description
diastolic blood pressure (mmHg)
Time Frame
at baseline and at the last visit (after 6 weeks)
Title
Adverse event
Description
Registration of all adverse events (number and severity of events)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gendre, MD
Organizational Affiliation
BioFortis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biofortis SAS
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of scFOS on Increase in Stool Frequency in Constipated People

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