Status:
COMPLETED
PTM202 and Modulation of Host Resistance to Diarrheagenic E. Coli
Lead Sponsor:
NIZO Food Research
Collaborating Sponsors:
PanTheryx, Inc.
Conditions:
Traveler's Diarrhea
Eligibility:
MALE
18-55 years
Phase:
NA
Brief 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, subject...
Detailed Description
The APA12/PANTER study is a randomized, double-blind, placebo-controlled, parallel intervention study of 3 weeks in 72 healthy adults. The study will include 2 arms; PTM202 and placebo. Subjects will ...
Eligibility Criteria
Inclusion
- 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;
- Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years;
- Willing to comply with study procedures, including collection of stool samples;
- Willingness to abstain from high calcium containing products;
- Willingness to abstain from alcoholic beverages three days before, during and for four days after diarrheagenic E. coli challenge;
- Willingness to abstain from antibiotics, norit, laxatives, nonsteroidal anti-inflammatory drugs (OTC), opiates, antacids, proton pump inhibitors, and antimotility agents (e.g., loperamide) on the three days before, during and for four days after diarrheagenic E. coli challenge.
- Willingness to abstain from probiotics three days before, during and for four days after diarrheagenic E. coli challenge;
- Willingness to give up blood donation starting 1 month prior to study start and during the entire study;
Exclusion
- 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;
- History of microbiologically confirmed ETEC or cholera infection in last 3 years;
- Known allergy to the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and penicillins;
- Known allergy to soy, milk- and/or egg;
- Mental status that is incompatible with the proper conduct of the study;
- Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years;
- Reported average stool frequency of \<1 or \>3 per day;
- 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 dosing, OR planned travel to endemic countries during the length of the study;
- Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholesterol lowering agents, antacids, proton pump inhibitors and immune suppressive agents (up till 3 months prior to inclusion);
- Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to inclusion;
- Vegans.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2018
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03301103
Start Date
December 7 2017
End Date
March 16 2018
Last Update
July 18 2018
Active Locations (1)
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1
NIZO
Ede, Gelderland, Netherlands, 6718ZB