The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection (NCT03596827) | Clinical Trial Compass
CompletedNot Applicable
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
Netherlands30 participantsStarted 2018-09-26
Plain-language summary
The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection. In order to make the model also suitable for dietary interventions that are aimed at support of the protective response against reinfection, the immune response triggered by the primary infection should be suboptimal. The MIRRE pilot study is set up to determine how much the primary inoculation dose of diarrheagenic E. coli should be lowered in order to result in a reduced protective response upon a secondary infection.
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male
. Age between 18 and 55 years.
. BMI ≥18.5 and ≤30.0 kg/m2.
. Healthy as assessed by the NIZO health questionnaire.
. Ability to follow Dutch verbal and written instructions.
. Availability of internet connection.
. Signed informed consent.
. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Acute gastroenteritis in the 2 months prior to inclusion
. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
. Disease of the GI tract, liver, gall bladder, kidney, thyroid gland (self-reported), except for appendicitis.
. History of microbiologically confirmed ETEC or cholera infection within 3 years prior to inclusion.
. 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 inclusion, OR planned travel to endemic countries during the length of the study.
. Vaccination for, or ingestion of cholera within 3 years prior to inclusion, including studies at NIZO.
. Occupation involving handling of ETEC or Vibrio cholerae currently, or within 3 years prior to inclusion.
. Vaccination for, or ingestion of ETEC or E coli heat labile toxin, including E. coli challenge studies at NIZO.