Epidemiology of H. Pylori Transmission

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT02740140
Collaborator
Santa Clara Valley Health & Hospital System (Other)
1,750
2
61
875
14.3

Study Details

Study Description

Brief Summary

This observational epidemiologic study with nested cross-sectional and longitudinal aims will evaluate host immune response to mixed chronic infections (Helicobacter pylori, latent tuberculosis, intestinal helminthiasis) in recent US immigrants.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1750 clinically-well, adult (age 18-55 years), recent immigrants (<2 years U.S. residence), referred through cooperating public health clinics in the Santa Clara Valley area, CA will be screened for H. pylori, helminth, and latent tuberculosis infections ["Screening" population]. Of these 1750, 426 will be selected for more intensive study (Cohort population), 105 of whom will receive baseline endoscopy. Of those selected for the cohort, 300 are expected to complete a 9-month follow-up assessment, 75 of whom are expected to undergo a second follow-up endoscopy.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Epidemiology of H. Pylori Transmission and Immunoepidemiology of Concomitant Infections
    Study Start Date :
    Jun 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Jul 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Change in cytokine responses from baseline at 9 months in TB and H. pylori antigen-induced PBMC before and after provider managed treatment of latent TB or helminth infection [Baseline and 9 months after treatment for either latent TB or helminth infections; analyzed after all subjects recruited (3 years of recruitment plus 9 months follow-up).]

    Secondary Outcome Measures

    1. Correlation of cytokine response to TB antigens and helminths with humoral responses to infections with H. pylori. [Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.]

    2. Population prevalence of individual and joint infections with H pylori, latent tuberculosis, heminthiasis in recent immigrant to northern California [Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.]

      We compare prevalence of these infections in recent immigrants by geographic area

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Between 18-55 years of age

    • Either sex

    • If female not pregnant or breastfeeding

    • Lived in the United States less than 2 years

    • Healthy

    • Scheduled for Tuberculosis Skin Test (TST)

    Exclusion Criteria:
    • Under 18 and older than 55 years of age,

    • Pregnant or breastfeeding

    • Have lived in Unites States more that 2 years

    • Chronic illness

    • Not planning to get a TST

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Santa Clara Public Health Clinics San Jose California United States 95122
    2 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University
    • Santa Clara Valley Health & Hospital System

    Investigators

    • Principal Investigator: Julie Parsonnet, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Julie Parsonnet, Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02740140
    Other Study ID Numbers:
    • SU-10182007-743
    First Posted:
    Apr 15, 2016
    Last Update Posted:
    Apr 15, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Julie Parsonnet, Professor, Stanford University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 15, 2016