Effect of scFOS on Increase in Stool Frequency in Constipated People

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Functional Constipation, Healthy

Intervention / Treatment
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* Dietary Supplement: scFOS
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: scFOS<br>scFOS consumed at 5g/day for 6 weeks | Dietary Supplement: scFOS<br>* daily intake for 6 weeks<br>|
| Placebo Comparator: Placebo<br>maltodextrin consumed at 5g/day for 6 weeks | Dietary Supplement: Maltodextrin<br>* daily intake for 6 weeks<br>|

What is the study measuring?
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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 |