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Clinical Experiment of H. Pylori Transmission (SIFT-EPEC)

This study is currently recruiting participants.
Verified by Stanford University, October 2007

Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00549224
  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
Helicobacter Pylori Infection
Achlorhydria
Biological: Enteropathogenic E. coli

MedlinePlus related topics:   Diarrhea   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Non-Randomized, Open Label, Single Group Assignment
Official Title:   Effect of Gastric Acid and H. Pylori Infection on Infection With Enteropathogenic E. Coli

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Development of diarrhea [ Time Frame: 48 hours after ingestion of E. coli ]

Secondary Outcome Measures:
  • Intensity of diarrhea [ Time Frame: 48 hours after ingestion of E. coli ]

Estimated Enrollment:   60
Study Start Date:   August 2005
Estimated Study Completion Date:   February 2008

Intervention Details:
    Biological: Enteropathogenic E. coli
    Both study arms, those infected with H. pylori and those without infection will ingest 1 x 10^9 enteropathogenic E. coli
  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: NCT00549224

Contacts
Contact: Julie Parsonnet, MD     650-725-4561     parsonnt@stanford.edu    
Contact: Alicia H. Chang, MD, MS     650-724-4941     achang2@stanford.edu    

Locations
United States, California
Stanford University     Recruiting
      Stanford, California, United States, 94305
      Principal Investigator: Julie Parsonnet, MD            

Sponsors and Collaborators
Stanford University

Investigators
Principal Investigator:     Julie Parsonnet, MD     Stanford University    
  More Information

Study ID Numbers:   18489, DK53689 PAFYB
First Received:   October 23, 2007
Last Updated:   October 24, 2007
ClinicalTrials.gov Identifier:   NCT00549224
Health Authority:   United States: Institutional Review Board

Keywords provided by Stanford University:
Helicobacter pylori  
hypochlorhydria  
EPEC  
enteropathogenic  
achlorhydria  

Study placed in the following topic categories:
Bacterial Infections
Metabolic Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases
Achlorhydria
Helicobacter Infections
Metabolic disorder
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Communicable Diseases
Infection
Acid-Base Imbalance

ClinicalTrials.gov processed this record on September 05, 2008




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