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:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01709266
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Male
* Age 20-55 yrs
* Availability of internet connection
* Willingness to replace habitual dairy product intake with the supplied low-calcium soy products
* Willingness to abstain from products with high amounts of prebiotic fibers and from products with probiotics (except for the supplied one) starting 1 month prior to study start
* Willingness to give blood donation from 1 month before the start of the experiment and during the entire experimental period.
Exclusion Criteria:
* Current or previous underlying disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported)
* Allergy to milk products or lactose intolerance (self-reported), since the capsules may contain milk traces from culture media
* Allergy to soy products (self-reported)
* Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressive agents (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion).
* High titer serum antibodies against ETEC (10 ml blood sample collected at screening)
* Vegetarians
* Vegans
* Heavy alcohol use (\>4 consumptions/day or \>20/week)
* Drug use
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01709266
Study Brief:
Protocol Section:
NCT01709266