Clinical Experiment of Helicobacter Pylori Transmission

This study has been completed.

First Received on October 25, 2007. Last Updated on September 6, 2011 History of Changes

Sponsor:	Stanford University
Information provided by (Responsible Party):	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:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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
ClinicalTrials.gov Identifier:	NCT00550368 History of Changes
Obsolete Identifiers:	NCT00549224
Other Study ID Numbers:	688
Study First Received:	October 25, 2007
Last Updated:	September 6, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Achlorhydria
Stomach Diseases
Gastrointestinal Diseases

Digestive System Diseases
Acid-Base Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on February 09, 2012