The effect of galacto-oligosaccharides in constipated adults

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

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.