Clinical Experiment of Helicobacter Pylori Transmission - Tabular View

Tracking Information

First Received Date ^ICMJE

October 25, 2007

Last Updated Date

June 16, 2008

Start Date ^ICMJE

August 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Development of diarrhea

Original Primary Outcome Measures ^ICMJE

Level of antigen-specific immune response [ Time Frame: 6 months of follow-up ]

Change History

Complete list of historical versions of study NCT00550368 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Intensity of diarrhea

Original Secondary Outcome Measures ^ICMJE

Patterns of immune response by PBMCs in response to antigen-specific challenge. [ Time Frame: 6 months of follow-up. ]

Descriptive Information

Brief Title ^ICMJE

Clinical Experiment of Helicobacter Pylori Transmission

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Infection
Achlorhydria

Intervention ^ICMJE

Biological: Biological intervention: Enteropathogenic E. coli

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years to 59 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00550368

Responsible Party

Study ID Numbers ^ICMJE

688

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Julie Parsonnet

Stanford University

Information Provided By

Stanford University

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP