PTM202 and Modulation of Host Resistance to Diarrheagenic E. Coli (NCT03301103) | Clinical Trial Compass
CompletedNot Applicable
PTM202 and Modulation of Host Resistance to Diarrheagenic E. Coli
Netherlands72 participantsStarted 2017-12-07
Plain-language summary
The APA12/PANTER study is a parallel 3-weeks intervention study. Subjects will be randomly assigned to one of two treatment groups; placebo or PTM202 (n=36 per group). After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli at study day 14. At various time points before and after diarrheagenic E. coli challenge an online diary will be kept to record information on stool consistency, frequency and severity of symptoms and stool samples will be collected to determine total fecal wet weight and percentage of fecal wet weight.
Who can participate
Age range18 Years – 55 Years
SexMALE
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Inclusion criteria
✓. Male;
✓. Age between 18 and 55 years;
✓. BMI ≥18 and ≤27 kg/m2;
✓. Healthy as assessed by the NIZO food research medical questionnaire.
✓. Ability to follow 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
✕. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV);
✕. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported);
✕. Diarrheagenic E. coli strain (as used in the study) detected in fecal sample at screening;
✕. Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use);
✕. High titer serum antibodies against CFA-II diarrheagenic E. coli strain (as used in the study) at screening;
✕
What they're measuring
1
Stool consistency
Timeframe: Before challenge (Day 11-13), After challenge (Day 14-18)
2
Relative fecal wet weight
Timeframe: Before challenge (Day 11-13), After challenge (Day 14-18)