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| Tracking Information | |||||
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| First Received Date ICMJE | October 25, 2007 | ||||
| Last Updated Date | November 24, 2009 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Development of diarrhea [ Time Frame: 48 hours ] [ Designated as safety issue: No ] | ||||
| 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 [ Time Frame: 48 hours ] [ Designated as safety issue: No ] | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Biological: Biological intervention: Enteropathogenic E. coli | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | April 2009 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| 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 |
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| 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 | Julie Parsonnet, Stanford University School of Medicine | ||||
| Study ID Numbers ICMJE | 688 | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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