The effect of galacto-oligosaccharides in constipated adults
- Conditions
- constipationhard stool10017977
- Registration Number
- NL-OMON49026
- Lead Sponsor
- FrieslandCampina Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 132
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Self-reported stool frequency, assessed weekly, in weekly in online<br /><br>questionnaires</p><br>
- Secondary Outcome Measures
Name Time Method <p>Self-reported stool consistency, assessed weekly in online questionnaires with<br /><br>the Bristol 7-point stool scale. </p><br>