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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT00198796

Public ClinicalTrials.gov record NCT00198796. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 1:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic E. Coli (ETEC) Challenge Strains That Express Colonization Factors CS17 and CFA/I

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00198796
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
5 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2005
Primary completion
Feb 21, 2007
Completion
May 29, 2007
Last update posted
Apr 10, 2017

2005 – 2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
General Clinical Research Center Baltimore Maryland 21205

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00198796, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 10, 2017 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00198796 live on ClinicalTrials.gov.

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