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PTM202 and Modulation of Host Resistance to Diarrheagenic E. Coli

NCT03301103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-07-18

No results posted yet for this study

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.

Conditions

  • Traveler's Diarrhea

Interventions

BIOLOGICAL

E. coli strain E1392-75-2A

After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14).

DEVICE

PTM202

PTM202 is a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg.

Sponsors & Collaborators

  • PanTheryx, Inc.

    collaborator INDUSTRY

  • NIZO Food Research

    lead OTHER

Principal Investigators

  • Van Schaik · NIZO Food Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2018-01-23
Completion
2018-03-16

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301103 on ClinicalTrials.gov