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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT03301103
Eligibility Criteria:
Inclusion Criteria:
1. Male;
2. Age between 18 and 55 years;
3. BMI ≥18 and ≤27 kg/m2;
4. Healthy as assessed by the NIZO food research medical questionnaire.
5. Ability to follow verbal and written instructions;
6. Availability of internet connection;
7. Signed informed consent;
8. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned;
9. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years;
10. Willing to comply with study procedures, including collection of stool samples;
11. Willingness to abstain from high calcium containing products;
12. Willingness to abstain from alcoholic beverages three days before, during and for four days after diarrheagenic E. coli challenge;
13. Willingness to abstain from antibiotics, norit, laxatives, nonsteroidal anti-inflammatory drugs (OTC), opiates, antacids, proton pump inhibitors, and antimotility agents (e.g., loperamide) on the three days before, during and for four days after diarrheagenic E. coli challenge.
14. Willingness to abstain from probiotics three days before, during and for four days after diarrheagenic E. coli challenge;
15. Willingness to give up blood donation starting 1 month prior to study start and during the entire study;
Exclusion Criteria:
1. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV);
2. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported);
3. Diarrheagenic E. coli strain (as used in the study) detected in fecal sample at screening;
4. Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use);
5. High titer serum antibodies against CFA-II diarrheagenic E. coli strain (as used in the study) at screening;
6. History of microbiologically confirmed ETEC or cholera infection in last 3 years;
7. Known allergy to the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and penicillins;
8. Known allergy to soy, milk- and/or egg;
9. Mental status that is incompatible with the proper conduct of the study;
10. Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years;
11. Reported average stool frequency of \<1 or \>3 per day;
12. Symptoms consistent with Travelers' Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study;
13. Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholesterol lowering agents, antacids, proton pump inhibitors and immune suppressive agents (up till 3 months prior to inclusion);
14. Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to inclusion;
15. Vegans.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03301103
Study Brief:
Protocol Section:
NCT03301103