Epidemiology of H. Pylori Transmission

Communicable Diseases Clinical Trial

Official title:

Epidemiology of H. Pylori Transmission and Immunoepidemiology of Concomitant Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740140
• Other study ID #: SU-10182007-743
• Status: Completed
• Phase: N/A
• First received: September 1, 2011
• Last updated: April 14, 2016
• Start date: June 2008
• Est. completion date: July 2013

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1750
• Est. completion date: July 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Locations

Country	Name	City	State
United States	Santa Clara Public Health Clinics	San Jose	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Santa Clara Valley Health & Hospital System

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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.	No
Secondary	Population prevalence of individual and joint infections with H pylori, latent tuberculosis, heminthiasis in recent immigrant to northern California	We compare prevalence of these infections in recent immigrants by geographic area	Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.	No