Effect of scFOS on Increase in Stool Frequency in Constipated People

Healthy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707002
• Other study ID #: PEC14513
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2018
• Source: Syral
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation
• Healthy

Intervention

Dietary Supplement:
• scFOS
daily intake for 6 weeks
• Maltodextrin
daily intake for 6 weeks

Locations

Country	Name	City	State
France	Biofortis SAS	Saint-Herblain

Sponsors (3)

Lead Sponsor	Collaborator
Syral	Biofortis Mérieux NutriSciences, CreaBio Rhone-Alpes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	heart rate (bit per minute)	at baseline and at the last visit (after 6 weeks)
Other	systolic blood pressure	systolic blood pressure (mmHg)	at baseline and at the last visit (after 6 weeks)
Other	diastolic blood pressure	diastolic blood pressure (mmHg)	at baseline and at the last visit (after 6 weeks)
Other	Adverse event	Registration of all adverse events (number and severity of events)	6 weeks
Primary	Stool frequency	Change in the number of stool per week between week at Baseline and the last week of supplementation	6 weeks
Secondary	Stool consistency	Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)	6 weeks
Secondary	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
Secondary	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