Clinical Experiment of H. Pylori Transmission - Full Text View

Clinical Experiment of H. Pylori Transmission (SIFT-EPEC)

This study is currently recruiting participants.

Verified by Stanford University, October 2007

First Received: October 23, 2007 Last Updated: October 24, 2007 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00549224

Purpose

The study proposes to test whether chronic infection with Helicobacter pylori protects individuals from symptomatic infection with enteropathogenic E. coli. The study will also evaluate the effect of gastric acidity in this relationship.

Condition	Intervention
Helicobacter Pylori Infection Achlorhydria	Biological: Enteropathogenic E. coli

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Official Title:	Effect of Gastric Acid and H. Pylori Infection on Infection With Enteropathogenic E. Coli

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Development of diarrhea [ Time Frame: 48 hours after ingestion of E. coli ]

Secondary Outcome Measures:

Intensity of diarrhea [ Time Frame: 48 hours after ingestion of E. coli ]

Estimated Enrollment:	60
Study Start Date:	August 2005
Estimated Study Completion Date:	February 2008

Intervention Details:

Both study arms, those infected with H. pylori and those without infection will ingest 1 x 10^9 enteropathogenic E. coli

Eligibility

Ages Eligible for Study:	35 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy

Exclusion Criteria:

prior gastrointestinal disease
prior treatment of H. pylori infection
immune suppression or deficiency
history of cancer, diabetes, or other co-morbidity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549224

Contacts

Contact: Julie Parsonnet, MD	650-725-4561	parsonnt@stanford.edu
Contact: Alicia H. Chang, MD, MS	650-724-4941	achang2@stanford.edu

Locations

United States, California
Stanford University	Recruiting
Stanford, California, United States, 94305
Principal Investigator: Julie Parsonnet, MD

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Julie Parsonnet, MD

Stanford University

More Information

No publications provided

Study ID Numbers:	18489, DK53689 PAFYB
Study First Received:	October 23, 2007
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00549224 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:

Helicobacter pylori
hypochlorhydria
EPEC
enteropathogenic
achlorhydria

Additional relevant MeSH terms:

Communicable Diseases
Metabolic Diseases
Digestive System Diseases
Stomach Diseases

Gastrointestinal Diseases
Achlorhydria
Infection
Acid-Base Imbalance

ClinicalTrials.gov processed this record on November 27, 2009