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 range18 Years – 55 Years
SexMALE
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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
✕. 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.