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Epidemiology of H. Pylori Transmission

Epidemiology of H. Pylori Transmission and Immunoepidemiology of Concomitant Infections

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02740140
Enrollment
1750
Registered
2016-04-15
Start date
2008-06-30
Completion date
2013-07-31
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communicable Diseases

Keywords

chronic coinfection

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.

Interventions

None listed

Sponsors

Santa Clara Valley Health & Hospital System
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frame
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 infectionBaseline 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

MeasureTime frameDescription
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 CaliforniaAssays 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026