Clinical Experiment of Helicobacter Pylori Transmission

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Julie Parsonnet, Stanford University

ClinicalTrials.gov Identifier:

NCT00550368

First received: October 25, 2007

Last updated: October 13, 2016

Last verified: October 2016

History of Changes

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 Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Effect of Gastric Acid and H. Pylori Infection on Infection With Enteropathogenic E. Coli

Resource links provided by NLM:

Drug Information available for: Escherichia coli

U.S. FDA Resources

Further study details as provided by Julie Parsonnet, Stanford University:

Primary Outcome Measures:

Development of Diarrhea [ Time Frame: 48 hours ]

Secondary Outcome Measures:

Intensity of Gastrointestinal Symptoms [ Time Frame: 48 hours ]
Composite gastrointestinal symptom score was on a scale from 0 (no symptoms) to 15 (severe symptoms). This composite was the sum of 5 self-reported, symptom scores, each ranging from 0 (none) to 3 (severe). The self-reported symptoms that subjects scored were: malaise, headache, nausea, vomiting, and loose stool.


Enrollment:	45
Study Start Date:	August 2005
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Helicobacter pylori negative Persons who tested negative for H. pylori by both serology and Urea breath test. All participants will receive the Biological intervention: Enteropathogenic E. coli.	Biological: Biological intervention: Enteropathogenic E. coli 5x10^8 or 1x10^9 organisms of EPEC were administered to all participants.
Experimental: Helicobacter pylori positive Persons who tested positive for H. pylori by both serology and Urea breath test. All participants will receive the Biological intervention: Enteropathogenic E. coli.	Biological: Biological intervention: Enteropathogenic E. coli 5x10^8 or 1x10^9 organisms of EPEC were administered to all participants.

Detailed Description:

Because H. pylori is an enteric infection, its prevalence may be linked to exposure to other enteric pathogens. Results of observational studies on the association between H. pylori and gastroenteritis, however, have been conflicting. Some have shown increased incidence of diarrhea in children with H. pylori infection, with one study attributing 11% of diarrhea cases to H. pylori. Other studies found no association, and still others found a protective effect of H. pylori against gastroenteritis. Dissecting out confounding from true physiological associations can be difficult in observational studies. To better elucidate the association between H. pylori and gastroenteritis, we performed a direct challenge experiment with a well-characterized gastrointestinal pathogen, enteropathogenic Escherichia coli (EPEC). EPEC is a leading cause of infantile gastroenteritis in the world and has a long history of safe use in human experiments. It is also acid sensitive: in our laboratory less than 0.001% of inoculated EPEC organisms survived at pH 2.5. Our goal was to test the hypothesis that chronic infection with H. pylori increases the risk of diarrheal illness after direct challenge with EPEC.

Eligibility


Ages Eligible for Study:	35 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Julie Parsonnet, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier:	NCT00550368 History of Changes
Obsolete Identifiers:	NCT00549224
Other Study ID Numbers:	688
Study First Received:	October 25, 2007
Results First Received:	February 23, 2016
Last Updated:	October 13, 2016

Additional relevant MeSH terms:


Infection Achlorhydria Stomach Diseases Gastrointestinal Diseases	Digestive System Diseases Acid-Base Imbalance Metabolic Diseases

ClinicalTrials.gov processed this record on July 11, 2017

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