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Completed

NCT Number: NCT01512875

S1119 Peruvian H. Pylori Water Contamination Study

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Peruana Cayetano Heredia

Lima, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • Hope Foundation
  • University of Michigan

Registry information

Official study title

Gastric Cancer and Helicobacter Pylori Infection in Lima, Peru: The Role of Water Contamination

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 19, 2012
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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