Skip to main content
OpenTrials
Completed

NCT Number: NCT03707002

Effect of scFOS on Increase 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Constipation Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis SAS

Saint-Herblain, 44800, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

scFOS

Dietary Supplement

daily intake for 6 weeks

Maltodextrin

Dietary Supplement

daily intake for 6 weeks

Primary outcomes

  1. Stool frequency

    Time frame: 6 weeks

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

Secondary outcomes

  1. Stool consistency

    Time frame: 6 weeks

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

  2. Frequency and severity of Gastrointestinal symptoms

    Time frame: 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

  3. Anxiety and depression

    Time frame: 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

Other outcomes

  1. Heart rate

    Time frame: at baseline and at the last visit (after 6 weeks)

    heart rate (bit per minute)

  2. systolic blood pressure

    Time frame: at baseline and at the last visit (after 6 weeks)

    systolic blood pressure (mmHg)

  3. diastolic blood pressure

    Time frame: at baseline and at the last visit (after 6 weeks)

    diastolic blood pressure (mmHg)

  4. Adverse event

    Time frame: 6 weeks

    Registration of all adverse events (number and severity of events)

Sponsors and collaborators

Lead sponsor

Syral

Industry

Collaborators

  • Biofortis Mérieux NutriSciences
  • CreaBio Rhone-Alpes

Registry information

Official study 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

Acronym: CONSYST

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2018
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.