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| Name | Class |
|---|---|
| Biofortis Mérieux NutriSciences | OTHER |
| CreaBio Rhone-Alpes | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scFOS | Active Comparator | scFOS consumed at 5g/day for 6 weeks |
|
| Placebo | Placebo Comparator | maltodextrin consumed at 5g/day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scFOS | Dietary Supplement | daily intake for 6 weeks |
| |
| Maltodextrin |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | heart rate (bit per minute) | at baseline and at the last visit (after 6 weeks) |
| systolic blood pressure | systolic blood pressure (mmHg) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gendre, MD | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis SAS | Saint-Herblain | 44800 | France |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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Identical sachets containing 5g of scFOS or placebo (maltodextrins)
| Dietary Supplement |
daily intake for 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
| 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 |
| at baseline and at the last visit (after 6 weeks) |
| diastolic blood pressure | diastolic blood pressure (mmHg) | at baseline and at the last visit (after 6 weeks) |
| Adverse event | Registration of all adverse events (number and severity of events) | 6 weeks |