NCT00550368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

December 6, 2016

Completed
Last Updated

December 6, 2016

Status Verified

October 1, 2016

Enrollment Period

3.7 years

First QC Date

October 25, 2007

Results QC Date

February 23, 2016

Last Update Submit

October 13, 2016

Conditions

InfectionAchlorhydria

Outcome Measures

Primary Outcomes (1)

  • Development of Diarrhea

    48 hours

Secondary Outcomes (1)

  • Intensity of Gastrointestinal Symptoms

    48 hours

Study Arms (2)

Helicobacter pylori negative

EXPERIMENTAL

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

Biological: Biological intervention: Enteropathogenic E. coli

Helicobacter pylori positive

EXPERIMENTAL

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

Biological: Biological intervention: Enteropathogenic E. coli

Interventions

Biological intervention: Enteropathogenic E. coliBIOLOGICAL

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

Helicobacter pylori negativeHelicobacter pylori positive

Eligibility Criteria

Age35 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

InfectionsAchlorhydria

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Julie Parsonnet
Organization
Stanford University
parsonnt@stanford.edu
(650) 725-4561

Study Officials

  • Julie Parsonnet

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 29, 2007

Study Start

August 1, 2005

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 6, 2016

Results First Posted

December 6, 2016

Record last verified: 2016-10

Locations

US(1)