Clinical trial NCT02740140: Epidemiology of H. Pylori Transmission
Official title: Epidemiology of H. Pylori Transmission and Immunoepidemiology of Concomitant Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Communicable Diseases
Keywords: chronic coinfection
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Santa Clara Valley Health & Hospital System
First posted: 2016-04-15
Enrollment: 1750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: Correlation of cytokine response to TB antigens and helminths with humoral responses to infections with H. pylori.
timeFrame: Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.
measure: Population prevalence of individual and joint infections with H pylori, latent tuberculosis, heminthiasis in recent immigrant to northern California
timeFrame: Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Public Health Clinics
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Julie Parsonnet
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.