S1119 Peruvian H. Pylori Water Contamination Study

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512875
• Other study ID #: S1119
• Status: Completed
• Phase: N/A
• First received: January 13, 2012
• Last updated: November 16, 2015
• Start date: December 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Locations

Country	Name	City	State
Peru	Universidad Peruana Cayetano Heredia	Lima

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Oncology Group	Hope Foundation, University of Michigan

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detect H. pylori in public drinking water of Lima Peru	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).	within 1 year of receving last sample	No
Secondary	Correlation of H. pylori in water and those of stomachs of patients with symptoms	To establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts.	Within 1 year of receiving last sample	No

External Links

•   SWOG website: protocol abstract for S1119