Clinical Experiment of Helicobacter Pylori Transmission

This study has been completed.

First Received: October 25, 2007 Last Updated: November 24, 2009 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00550368

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
Infection Achlorhydria	Biological: Biological intervention: Enteropathogenic E. coli

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intensity of diarrhea [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2005
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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: NCT00550368

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Julie Parsonnet

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Julie Parsonnet )
Study ID Numbers:	688
Study First Received:	October 25, 2007
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00550368 History of Changes
Health Authority:	United States: Institutional Review Board

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 February 08, 2010