NCT02740140

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

June 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

September 1, 2011

Last Update Submit

April 14, 2016

Conditions

Communicable Diseases

Keywords

chronic coinfection

Outcome Measures

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

    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 (2)

  • 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.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Santa Clara Public Health Clinics

San Jose, California, 95122, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (4)

  • Chang AH, Perry S, Du JN, Agunbiade A, Polesky A, Parsonnet J. Decreasing intestinal parasites in recent Northern California refugees. Am J Trop Med Hyg. 2013 Jan;88(1):191-7. doi: 10.4269/ajtmh.2012.12-0349. Epub 2012 Nov 13.

    PMID: 23149583BACKGROUND

  • Perry S, Chang AH, Sanchez L, Yang S, Haggerty TD, Parsonnet J. The immune response to tuberculosis infection in the setting of Helicobacter pylori and helminth infections. Epidemiol Infect. 2013 Jun;141(6):1232-43. doi: 10.1017/S0950268812001823. Epub 2012 Sep 7.

    PMID: 22954328BACKGROUND

  • Herrera V, Perry S, Parsonnet J, Banaei N. Clinical application and limitations of interferon-gamma release assays for the diagnosis of latent tuberculosis infection. Clin Infect Dis. 2011 Apr 15;52(8):1031-7. doi: 10.1093/cid/cir068.

    PMID: 21460320BACKGROUND

  • Perry S, Hussain R, Parsonnet J. The impact of mucosal infections on acquisition and progression of tuberculosis. Mucosal Immunol. 2011 May;4(3):246-51. doi: 10.1038/mi.2011.11. Epub 2011 Mar 16.

    PMID: 21412228BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum and PBMC

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Julie Parsonnet

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2011

First Posted

April 15, 2016

Study Start

June 1, 2008

Primary Completion

June 1, 2011

Study Completion

July 1, 2013

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

US(2)