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S1119 Peruvian H. Pylori Water Contamination Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01512875
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : November 17, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Helicobacter Pylori Infection

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.

Study Design

Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gastric Cancer and Helicobacter Pylori Infection in Lima, Peru: The Role of Water Contamination
Study Start Date : December 2011
Primary Completion Date : August 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
biopsy proven H. pylori
Patient must have lived in the districts of Lima, Peru listed in the protocol.


Outcome Measures

Primary Outcome Measures :
  1. Detect H. pylori in public drinking water of Lima Peru [ Time Frame: within 1 year of receving last sample ]
    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 :
  1. Correlation of H. pylori in water and those of stomachs of patients with symptoms [ Time Frame: Within 1 year of receiving last sample ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512875


Locations
Peru
Universidad Peruana Cayetano Heredia
Lima, Peru
Sponsors and Collaborators
Southwest Oncology Group
University of Michigan
Hope Foundation
Investigators
Principal Investigator: Manuel Valdivieso, M.D. Southwest Oncology Group
More Information

Additional Information:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01512875     History of Changes
Other Study ID Numbers: S1119
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

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

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