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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03707002
Other study ID # PEC14513
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date January 2017

Study information

Verified date October 2018
Source Syral
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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