constipation hard stool
Conditions
Interventions
The subjects, divided in 3 study groups (44 persons each) will consume either
one of the interventions:
GOS: Biotis* GOS Omni powder, containing 15.1 gr powder with 11 gr active GOS
(once per day)
Sponsors
FrieslandCampina Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Males and females Age * 18 years BMI *18,5 and * 28,0 kg m2. Healthy as assessed by the NIZO health questionnaire Self-reported constipation according to the Rome IV criteria with the following criteria (for the last 3 months): Fewer than three (3) bowel movements per week. And one or more of the criteria below: * Straining during at least 25% of all defecations * Lumpy or hard stools (BSFS 1-2) in at least 25% of defecations, * Sensation of incomplete evacuation for at least 25% of defecations, * Sensation of anorectal obstruction/blockage for at least 25% of defecations, * Manual manoeuvres to facilitate at least 25% of defecation (e.g., digital evacuation, support of the pelvic floor) *Willingness to abstain from laxatives during the study
Exclusion criteria
Exclusion criteria: - Major abdominal surgery interfering with GI function - Major co-morbidities,such as diagnosed inflammatory bowel disease, diagnosed celiac disease, diagnosed diverticulitis, a history of gastrointestinal tumors and other unforeseen co-morbidities, that may have an impact on the study results (as decided by the medical investigator) - Use of medication that may affect the results of the investigational product, such as physician prescribed laxatives, and medication that influences the motility of the GI tract -Use of antibiotics 90 days before the start of the study -Use of strict diets (Vegan diet, gluten free diet, or crash-diet with use of meal replacers) -Self-reported lactose-intolerance - Self reported cow's milk allergy - Diagnosed diabetes -Pregnant and lactating women -Expected change in lifestyle within 14 days before and during the trial period (i.e. diet, physical activity, smoking, alcohol consumption and medication use) -History of side effect with the use of prebiotic supplements -Use of alcoholic beverages for men > 28 units/week and >4/day; for women: >21 units/week and >3/day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported stool frequency, assessed weekly, in weekly in online questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported stool consistency, assessed weekly in online questionnaires with the Bristol 7-point stool scale. | — |
Countries
Netherlands
Outcome results
None listed