constipation decreased frequency of defecation
Conditions
Interventions
Placebo and one out of 3 dosages of short-chain fructo-oligosaccharide,
NutraFlora® scFOS, (Degree of Polymerisation of 3-5
2, 4 and 8 g/day) for 4
weeks. NutraFlora® scFOS will be given as oral chews.
Sponsors
Ingredion Incorporated
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 18-75 yr • Agree to study design (signed informed consent) • At least two of the following symptoms >=25% of the defecations (ROME III) with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to study start: o straining, lumpy or hard stool o sensation of incomplete evacuation o sensation of anorectal obstruction * blockage o use of manual manoeuvres o
Exclusion criteria
Exclusion criteria: • Currently participating in another clinical trial • Drug usage • Excessive alcohol usage (>4 consumptions/day or >20 consumptions/week) • Pregnancy or lactating • Underlying disease of the GI-tract or previous laparotomy, except cholecystectomy and appendectomy. • Use of antibiotics within 1 month prior to inclusion • Vegetarians • Weight loss >5 kg within 1 month prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter is the number of complete bowel movements per day in subjects with functional constipation according to Rome III criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are Stool consistency (Bristol Stool Scale), Stool frequency, Severity of symptoms (Constipation Scoring System; CSS) and Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL). Other study parameters: Microbiota profile, fecal Bifidobacteria, Lactobacilli, Clostridia, E. coli and total bacterial count. Blood samples will be taken at baseline and end of treatment and stored for later analysis. | — |
Countries
Netherlands
Outcome results
None listed