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 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT02541695
Eligibility Criteria:
Inclusion criteria:
1. Ability to follow verbal and written instructions;
2. Age between 18 and 55 years;
3. Availability of internet connection;
4. BMI ≥20 and ≤27 kg/m2;
5. Healthy as assessed by the NIZO food research medical questionnaire;
6. Male subjects;
7. Signed informed consent;
8. Voluntary participation;
9. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned;
10. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years;
11. Willing to comply with study procedures;
12. Willingness to abstain from high calcium containing products.
13. Willingness to abstain from medications that contain acetaminophen, aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs, (OTC) antacids and antimotility agents (eg, loperamide) on the three days before, during and 3 days after diarrhoeagenic E. coli challenge.
14. Willingness to abstain from alcoholic beverages three days before, during and three days after diarrhoeagenic 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. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported);
2. Diarrhoeagenic E.coli strain (as used in the study) detected in fecal sample at screening;
3. Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use);
4. Evidence of IgA deficiency (serum IgA \< 7 mg/dL or below the limit of detection of assay).
5. High titer serum antibodies against CFA-II diarrhoeagenic 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. Mental status that is incompatible with the proper conduct of the study;
9. Not having a general practitioner, not allowing disclosure of participation to the general practitioner or not allow to inform the general practitioner about abnormal results.
10. Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years.
11. Participation in any clinical trial including blood sampling and/or administration of substances starting 1 month prior to study start and during the entire study;
12. Personnel of NIZO food research, their partner and their first and second degree relatives;
13. Reported average stool frequency of \<1 or \>3 per day;
14. Symptoms consistent with Travelers' Diarrhoea 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.
15. Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, antacids H2 receptor antagonists or proton pump inhibitors or immune suppressive agents (up till 3 months prior to inclusion);
16. Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to inclusion;
17. Vegetarians and vegans
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02541695
Study Brief:
Protocol Section:
NCT02541695