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Clinical Experiment of Helicobacter Pylori Transmission

Primary Purpose

Infection, Achlorhydria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biological intervention: Enteropathogenic E. coli
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infection

Eligibility Criteria

35 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers
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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Helicobacter pylori negative

Helicobacter pylori positive

Arm Description

Persons who tested negative for H. pylori by both serology and Urea breath test. All participants will receive the Biological intervention: Enteropathogenic E. coli.

Persons who tested positive for H. pylori by both serology and Urea breath test. All participants will receive the Biological intervention: Enteropathogenic E. coli.

Outcomes

Primary Outcome Measures

Development of Diarrhea

Secondary Outcome Measures

Intensity of Gastrointestinal Symptoms
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.

Full Information

First Posted
October 25, 2007
Last Updated
October 13, 2016
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00550368
Brief Title
Clinical Experiment of Helicobacter Pylori Transmission
Official Title
Effect of Gastric Acid and H. Pylori Infection on Infection With Enteropathogenic E. Coli
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Achlorhydria

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Helicobacter pylori negative
Arm Type
Experimental
Arm Description
Persons who tested negative for H. pylori by both serology and Urea breath test. All participants will receive the Biological intervention: Enteropathogenic E. coli.
Arm Title
Helicobacter pylori positive
Arm Type
Experimental
Arm Description
Persons who tested positive for H. pylori by both serology and Urea breath test. All participants will receive the Biological intervention: Enteropathogenic E. coli.
Intervention Type
Biological
Intervention Name(s)
Biological intervention: Enteropathogenic E. coli
Intervention Description
5x10^8 or 1x10^9 organisms of EPEC were administered to all participants.
Primary Outcome Measure Information:
Title
Development of Diarrhea
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Intensity of Gastrointestinal Symptoms
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Parsonnet
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Clinical Experiment of Helicobacter Pylori Transmission

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