Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT04104360
Eligibility Criteria:
Inclusion Criteria:
1. Based on medical history no gastrointestinal complaints can be defined.
2. Regular stool frequency ranging from 3 times/day - 3 times/week.
3. Body Mass Index (BMI) ≥ 20 and \< 30 kg/m2.
4. Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. \< 3kg).
5. Willing to be informed in case of unexpected findings.
Exclusion Criteria:
1. History of any disease or surgery interfering with the study aims, limiting participating or completing the study protocol.
2. Self-admitted human immunodeficiency virus-positive state.
3. Disease with a life expectancy shorter than 5 years.
4. Abdominal surgery interfering with gastrointestinal function, upon judgment of the medical doctor, who will decide on in- or exclusion based on the surgery applied.
5. Use of antibiotics within 90 days prior to the study.
6. Use of anticoagulation medication (except Ascal).
7. Use of proton pump inhibitors.
8. Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used.
9. Last colonoscopy within 90 days prior to the study.
10. Inadequate or painful (self-reported) colonoscopy undergone in the past.
11. American Society of Anesthesiologists (ASA) classification \> 2.
12. Smoking.
13. Pregnancy or lactation.
14. Plan to lose weight or follow a specific diet within the study period.
15. Alcohol intake \>14 units/week.
16. Use of laxatives within 14 days prior to the study.
17. Drug use.
18. 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.
19. History of side effects towards intake of prebiotic supplements.
20. Self-admitted lactose intolerance.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04104360
Study Brief:
Protocol Section:
NCT04104360