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Completed

NCT Number: NCT02740140

Epidemiology of H. Pylori Transmission

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.

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Key information

Conditions

Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Santa Clara Public Health Clinics, San Jose, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

    Time frame: 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 outcomes

  1. Correlation of cytokine response to TB antigens and helminths with humoral responses to infections with H. pylori.

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Santa Clara Valley Health & Hospital System

Registry information

Official study title

Epidemiology of H. Pylori Transmission and Immunoepidemiology of Concomitant Infections

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Apr 15, 2016
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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