The effect of galacto-oligosaccharides in constipated adults

Completed

Conditions: Constipation

Registration Number: NL-OMON23365

Lead Sponsor: FrieslandCampina

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 132

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):
oFewer than three bowel movements per week.
oAnd 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

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.