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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
186
daily intake for 6 weeks
daily intake for 6 weeks
Biofortis SAS
Saint-Herblain, France
Stool frequency
Change in the number of stool per week between week at Baseline and the last week of supplementation
Time frame: 6 weeks
Stool consistency
Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)
Time frame: 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
Time frame: 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
Time frame: 6 weeks
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