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Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic Escherichia Coli (ETEC) Challenge Strains

NCT00198796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-04-11

No results posted yet for this study

Summary

Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for 90 more minutes. After this challenge they will be monitored closely , and all stools will be collected, graded and weighed. On Day 5, or sooner if indicated, they will begin antibiotics to eradicate the challenge strain. They will be scheduled for discharge on Day 7 but may leave a few days earlier if early antibiotic treatment is given.

Hypothesis:

A challenge dose of 10(9) colony forming unit (CFU) of ETEC strain H10407, will cause diarrhea in at least 60% of subjects.

Conditions

Interventions

BIOLOGICAL

H10407

The primary objective of the proposed clinical investigation is to validate a dose for ETEC H10407 that will cause diarrhea in 50% or more of subjects without causing high output diarrhea

Sponsors & Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    collaborator OTHER

  • Naval Medical Research Center

    collaborator FED

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Robin McKenzie, M.D. · Johns Hopkins University

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-02-22
Completion
2007-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00198796 on ClinicalTrials.gov