Communicable DiseasesNCT02740140
Epidemiology of H. Pylori Transmission
An observational study of Communicable Diseases, run by Stanford University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Communicable Diseases
- How many people
- 1,750 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Santa Clara Public Health Clinics
San Jose, California, 95122
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Epidemiology of H. Pylori Transmission and Immunoepidemiology of Concomitant Infections
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.
Read the 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.
- Conditions
- Communicable Diseases
- Keywords
- chronic coinfection
- Medical subject headings
- Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
We compare prevalence of these infections in recent immigrants by geographic area
Measured: Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJun 2008
- Primary completionJun 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Communicable DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Clara Valley Health & Hospital System
- Responsible party
- Principal investigator, Julie Parsonnet, Stanford University
- Investigators
- Julie Parsonnet, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740140
- Sponsor's protocol ID
- SU-10182007-743
- Status last verified
- Apr 2016
- First submitted
- 1 Sep 2011
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23149583Perry 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.
PubMed 22954328Herrera 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.
PubMed 21460320Perry 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.
PubMed 21412228
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of H. Pylori Transmission and Immunoepidemiology of Concomitant Infections
- ClinicalTrials.gov ID
- NCT02740140
- Acronym / sponsor ID
- SU-10182007-743
- Conditions
- Communicable Diseases
- Keywords
- chronic coinfection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,750 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Santa Clara Valley Health & Hospital System
- Study start
- Jun 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Between 18-55 years of age
- Either sex
- If female not pregnant or breastfeeding
- Lived in the United States less than 2 years
- Healthy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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).
2 secondary outcomes
Correlation of cytokine response to TB antigens and helminths with humoral responses to infections with H. pylori.
Time frame: 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
Time frame: Assays performed when collected over three years from recruited subjects; analyzed at the end of three years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Background: PubMed 23149583Chang 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.
- Background: PubMed 22954328Perry 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.
- Background: PubMed 21460320Herrera 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.
- Background: PubMed 21412228Perry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Parsonnet principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communicable Diseases, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740140, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.