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 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT03188302
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities.
* Healthy female or male aged 18 years (inclusive) or older.
* Is willing and able to provide at least 3 stool samples during 2 collection periods of approximately 60 hours, to store the samples in appropriate conditions and to return the samples within the required timeframe.
* Is willing and able to complete a diary during the stool collection periods in order to collect information about form of the stools (based on the Bristol Stool Form Scale classification), bowel habit and sleep habit.
* Understands the Dutch or English language (reading, writing, speaking).
Exclusion Criteria:
* Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate in this trial.
* Is treated (i.e., currently treated, treated within 1 month before inclusion) for constipation, diarrhoea or any other illness, by use of antibiotics or any other treatment with impact on defecation.
* Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant.
* Is unable to refrain from or anticipates the use of disallowed medications, e.g., antibiotics, laxatives, anti-diarrheal medication.
* Has any history of drug and/or alcohol abuse.
* Any clinically significant disease which in the Investigator's opinion could interfere with the safety of study participants or with the results of the study.
* Participation in another interventional clinical study or receipt of any investigational product within 1 month before visit 1.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03188302
Study Brief:
Protocol Section:
NCT03188302