MIRRE STUDY: The protective immune response to attenuated enterotoxigenic Escherichia coli infection in healthy human subjects: a pilot study.

Completed

• Conditions: Gastroenteritis; Traveler's diarrhea; 10004018

• Registration Number: NL-OMON46336
• Lead Sponsor: IZO food research BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Male
2. Age between 18 and 55 years.
3. BMI *18.5 and *30.0 kg/m2.
4. Healthy as assessed by the NIZO food research medical questionnaire.

Exclusion Criteria

1. Acute gastroenteritis in the 2 months prior to inclusion
2. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
3. Disease of the GI tract, liver, gall bladder, kidney, thyroid gland (self-reported), except for appendicitis.
4. History of microbiologically confirmed ETEC or cholera infection within 3 years prior to inclusion.
5. 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.
6. Vaccination for, or ingestion of cholera, including studies at NIZO, within 3 years prior to inclusion.
7. Occupation involving handling of ETEC or Vibrio cholerae currently, or within 3 years prior to inclusion.
8. Vaccination for, or ingestion of ETEC or E coli heat labile toxin, including E. coli challenge studies at NIZO.
9. Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use, and not willing/able to stop this during the study.
10. Known allergy to the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and penicillins.
11. Reported average stool frequency of >3 per day or <1 per 2 days.
12. Use of antibiotics, (during 6 months prior to inclusion), norit, laxatives cholestyramine, antacids H2 receptor antagonists or proton pump inhibitors or immune suppressive agents (during 3 months prior to inclusion).
13. Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies).
14. Vegans.
15. Mental status that is incompatible with the proper conduct of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter:<br /><br>* Specific antibody titer, serum IgG-CFA/II antibody levels at second E. coli<br /><br>inoculation.</p><br>