Constipation
Conditions
Interventions
High dose of galacto-oligosaccharides, low dose of galacto-oligosaccharides and the control group receiving maltodextrin
Sponsors
FrieslandCampina
Eligibility
Inclusion criteria
Inclusion criteria: Substantial: • 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): o Fewer than three bowel movements per week. o And one or more of the criteria below: ? straining during at least 25% of all defecations ? lumpy or hard stools (Bristol Stool Form Scale 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 defaecaltion (e.g., digital evacuation, support of the pelvic floor) Procedural: • Ability to follow Dutch verbal and written instructions • Availability of internet connection • Signed informed consent • Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned. • Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years. • Willing to comply with study procedures, including collection of stool samples and alcohol restriction of maximum 2 consumptions per day • Willing to abstain from non-prescription laxatives (starting at least 2 weeks before the start of the baseline period) • Willing to abstain from drugs use during the study
Exclusion criteria
Exclusion criteria: Substantial: • 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 protein 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 Procedural: • Not having a general practitioner, not allowing disclosure of participation to the general practitioner or not allow to inform the general practitioner about abnormal results. • Participation in any clinical trial including blood sampling and/or administration of substances starting 1 month prior to study start and during the entire study. • Personnel of NIZO or FrieslandCampina, their partner and their first and second degree relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool consistency | — |
Contacts
Public ContactDominique ten Haaf
FrieslandCampina
Outcome results
None listed