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OpenTrials
Completed

NCT Number: NCT00550368

Clinical Experiment of Helicobacter Pylori Transmission

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.

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Key information

Age range

35 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological intervention: Enteropathogenic E. coli

Biological

5x10^8 or 1x10^9 organisms of EPEC were administered to all participants.

Primary outcomes

  1. Development of Diarrhea

    Time frame: 48 hours

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Effect of Gastric Acid and H. Pylori Infection on Infection With Enteropathogenic E. Coli

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 29, 2007
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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