Epidemiology of H. Pylori Transmission

Completed

• Conditions: Communicable Diseases

• Registration Number: NCT02740140
• Lead Sponsor: Stanford University

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.

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 Timeline

• Study Start: 2008-06
• Primary Completion: 2011-06
• Study First Submitted: 2011-09-01
• Study Completion: 2013-07
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1750

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)

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (2)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Santa Clara Public Health Clinics; 🇺🇸 San Jose, California, United States