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Peruvian H. Pylori Water Contamination Study

This study is currently recruiting participants.
Verified February 2013 by Southwest Oncology Group
Sponsor:
Collaborators:
University of Michigan
Hope Foundation
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01512875
First received: January 13, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

The objective of this study is to elucidate the role of drinking water derived from the public source in Lima, Peru and transmission of H. pylori infection using genotypic techniques.


Condition
Helicobacter Pylori Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gastric Cancer and Helicobacter Pylori Infection in Lima, Peru: The Role of Water Contamination

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Detect H. pylori in public drinking water of Lima Peru [ Time Frame: within 1 year of receving last sample ] [ Designated as safety issue: No ]
    To detect the presence of Helicobacter Pylori (H. pylori) in the drinking water derived from the public network by molecular and genomic techniques in districts of Lima, Peru (districts detailed in protocol).


Secondary Outcome Measures:
  • Correlation of H. pylori in water and those of stomachs of patients with symptoms [ Time Frame: Within 1 year of receiving last sample ] [ Designated as safety issue: No ]
    To establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts.


Biospecimen Retention:   Samples With DNA

tissue


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
biopsy proven H. pylori
Patient must have lived in the districts of Lima, Peru listed in the protocol.

Detailed Description:

The objective of this study is to detect the presence of Helicobacter Pylori in the drinking water derived from the public network by molecular and genomic techniques in districts of Lima (Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Martin de Porres, Villa El Salvador, and Villa Maria del Triunfo) with high and low incidence of gastric carcinoma. The secondary objective of this study is to establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Residents of the following districts of Lima, Peru: Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Luis, San Martin de Porres, Via El Salvador, Villa Maria del Triunfo.

Criteria

Inclusion Criteria:

  • adults between the ages of 21-70 years old who have lived for more than 10 years in the Lima districts listed in protocol,
  • who have a biopsy proven diagnosis of infection by H. pylori.
  • participants must be in good general condition, mentally competent and able to provide informed consent;
  • must not show evidence of dehydration or jaundice;
  • must be willing to complete the patient questionnaires.
  • participants must not have known allergies to any of the antibiotics used in the study.

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512875

Contacts
Contact: Alejandro J. Bussalleu, M.D. 001-511-482-3435 vracad@oficinas-upch.pe
Contact: Italo Novoa Reyes, M.D. 011-511-658-7543 italo.novoa@upch.pe

Locations
Peru
Universidad Peruana Cayetano Heredia Recruiting
Lima, Peru
Contact: Alejandro J. Bussalleu, M.D.     001-511-482-3435     vracad@oficinas-upch.pe    
Contact: Italo Novoa Reyes, M.D.     011-511-658-7543     italo.novoa@upch.pe    
Sponsors and Collaborators
Southwest Oncology Group
University of Michigan
Hope Foundation
Investigators
Principal Investigator: Manuel Valdivieso, M.D. SWOG
  More Information

Additional Information:
SWOG website: protocol abstract for S1119  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01512875     History of Changes
Other Study ID Numbers: S1119
Study First Received: January 13, 2012
Last Updated: February 27, 2013
Health Authority: Peru: Ministry of Health

Keywords provided by Southwest Oncology Group:
Helicobacter pylori
water contamination
Lima, Peru

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 17, 2013