Status:
COMPLETED
Galacto-oligosaccharides and Intestinal Activity
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Healthy Adults
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Dietary intake of galacto-oligosaccharides (GOS) may have beneficial effects on host health by affecting the microbiota composition and -activity. So far studies focused on analyses in fecal samples, ...
Eligibility Criteria
Inclusion
- Based on medical history no gastrointestinal complaints can be defined.
- Regular stool frequency ranging from 3 times/day - 3 times/week.
- Body Mass Index (BMI) ≥ 20 and \< 30 kg/m2.
- Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. \< 3kg).
- Willing to be informed in case of unexpected findings.
Exclusion
- History of any disease or surgery interfering with the study aims, limiting participating or completing the study protocol.
- Self-admitted human immunodeficiency virus-positive state.
- Disease with a life expectancy shorter than 5 years.
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the medical doctor, who will decide on in- or exclusion based on the surgery applied.
- Use of antibiotics within 90 days prior to the study.
- Use of anticoagulation medication (except Ascal).
- Use of proton pump inhibitors.
- Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used.
- Last colonoscopy within 90 days prior to the study.
- Inadequate or painful (self-reported) colonoscopy undergone in the past.
- American Society of Anesthesiologists (ASA) classification \> 2.
- Smoking.
- Pregnancy or lactation.
- Plan to lose weight or follow a specific diet within the study period.
- Alcohol intake \>14 units/week.
- Use of laxatives within 14 days prior to the study.
- Drug use.
- Administration of probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principle investigator), in the 14 days prior to the study.
- History of side effects towards intake of prebiotic supplements.
- Self-admitted lactose intolerance.
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04104360
Start Date
September 17 2019
End Date
September 15 2024
Last Update
March 24 2025
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX