NCT01512875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

January 13, 2012

Last Update Submit

November 16, 2015

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriwater contaminationLima, Peru

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Correlation of H. pylori in water and those of stomachs of patients with symptoms

    Within 1 year of receiving last sample

Study Arms (1)

biopsy proven H. pylori

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

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue

Study Officials

  • Manuel Valdivieso, M.D.

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 19, 2012

Study Start

December 1, 2011

Primary Completion

August 1, 2013

Study Completion

November 1, 2013

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

PE(1)