S1119 Peruvian H. Pylori Water Contamination Study

NCT ID: NCT01512875

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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biopsy proven H. pylori

Patient must have lived in the districts of Lima, Peru listed in the protocol.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Hope Foundation

OTHER

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuel Valdivieso, M.D.

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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Universidad Peruana Cayetano Heredia

Lima, , Peru

Site Status

Countries

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Peru

Other Identifiers

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S1119

Identifier Type: -

Identifier Source: org_study_id