PTM202 and Modulation of Host Resistance to Diarrheagenic E. Coli

NCT03301103 | Completed DMC

• 1 other identifier: NL62453.028.17
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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, 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

Keywords

Nutrition; Gastroenteritis; Traveler's diarrhea; E. coli

Outcome Measures

Primary Outcomes (2)

• Stool consistency

  Change in stool consistency score (questionnaire) before and after E. coli challenge

  Before challenge (Day 11-13), After challenge (Day 14-18)

• Relative fecal wet weight

  Change in relative fecal wet weight (freeze-drying) before and after E. coli challenge

  Before challenge (Day 11-13), After challenge (Day 14-18)

Secondary Outcomes (3)

• Stool frequency

  Before challenge (Day 11-13), After challenge (Day 14-18)

• Total fecal wet weight

  Before challenge (Day 11-13), After challenge (Day 14-18)

• Gastro-intestinal symptoms

  Before challenge (Day 11-13), After challenge (Day 14-18)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo will consist of low-lactose isonitrogenous soy product, and will be matched in appearance and flavour to PTM202. 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).

Biological: E. coli strain E1392-75-2A

PTM202

EXPERIMENTAL

PTM202 is a dry powder for reconstitution, comprised of a proprietary mixture of dried bovine colostrum and dried whole egg. 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).

Biological: E. coli strain E1392-75-2A; Device: PTM202

Interventions

E. coli strain E1392-75-2A BIOLOGICAL

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).

PTM202; Placebo

PTM202 DEVICE

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

PTM202

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Gender identity is self-reported by the subjects through a questionnaire.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Vegans.

Sponsors & Collaborators

• NIZO Food Research: lead
• PanTheryx, Inc.: collaborator

Study Sites (1)

NIZO

Ede, Gelderland, 6718ZB, Netherlands

Location

MeSH Terms

Conditions

Gastroenteritis; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Van Schaik

  NIZO Food Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All researchers of the project team will be kept blind to assignment of treatment, and so will be the study subjects.The placebo will be matched in appearance and flavour to PTM202.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The APA12/PANTER study is a randomized, double-blind, placebo-controlled, parallel intervention study of 3 weeks in 72 healthy adults. 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). At study day 14, 15 and 16 subjects will receive either placebo or PTM202, a dietary formula containing dried bovine colostrum and dried whole egg.

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: October 4, 2017
• Study Start: December 7, 2017
• Primary Completion: January 23, 2018
• Study Completion: March 16, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)