A Study of Acequias Contamination & Association of Infectious Diseases in Peru

A major water supply utilized in the Lambayeque region are acequias. Acequias are irrigation canals that are utilized by the agriculture industry for the cultivation of consumables. Utilization of contaminated water to irrigate consumables can lead to foodborne illnesses. Contamination studies on the acequias in the Lambayeque region have not been performed to date. The purpose of this study is to test contamination of acequias in 9 districts in Lambayeque and determine if a difference in infection rates exists in districts with contaminated acequias vs. districts without contaminated acequias for the following diseases: H. pylori, Adenovirus, Rotavirus.

Study Overview

• Status: Unknown
• Conditions: Water-Related Diseases
• Intervention / Treatment: Diagnostic test: Adenovirus; Diagnostic test: Rotavirus; Diagnostic test: H. pylori

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• Peru
  • Lambayeque
    • Patapo, Lambayeque, Peru
      • Recruiting
      • BioRed
      • Contact: Lozado Dominguez
    • Pimentel, Lambayeque, Peru
      • Recruiting
      • BioRed
      • Contact: Lozado Dominguez
    • Pomalca, Lambayeque, Peru
      • Recruiting
      • BioRed
      • Contact: Lozado Dominguez
    • Pucala, Lambayeque, Peru
      • Recruiting
      • BioRed
      • Contact: Lozado Dominguez
    • Tuman, Lambayeque, Peru
      • Recruiting
      • BioRed
      • Contact: Lozado Dominguez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

There is no study population in phase I as it is focused on the districts and their corresponding acequias. Phase II of this study will include participants 18 years of age or older who consent to participate and are from the following districts: Eten, Pomalca, Pimentel, Patapo, Pucala, Santa Rosa, Reque, Monsefu and Sana.

Description

Inclusion Criteria:

• Currently reside in one of the following districts: Eten, Pomalca, Pimentel, Patapo, Pucala, Santa Rosa, Reque, Monsefu and Sana
• 18 years of age or older
• Consent to participate

Exclusion Criteria:

• Currently taking antiviral or antimicrobial medication

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Contaminated acequias	Diagnostic test: Adenovirus; Diagnostic test for the presence of the adenovirus in the population groups; Diagnostic test: Rotavirus; Diagnostic test for the presence of the Rotavirus in the population groups; Diagnostic test: H. pylori; Diagnostic test for the presence of H. pylori infection in the population groups
Non-contaminated acequias	Diagnostic test: Adenovirus; Diagnostic test for the presence of the adenovirus in the population groups; Diagnostic test: Rotavirus; Diagnostic test for the presence of the Rotavirus in the population groups; Diagnostic test: H. pylori; Diagnostic test for the presence of H. pylori infection in the population groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contamination of acequias	Presence of Fecal Coliforms in the acequias	March 20th - April 1st

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of population with infections	Proportion of populations with adenovirus, rotavirus and H. pylori infections	March 20th - May 1st

Collaborators and Investigators

• Sponsor: BioRed LLC
• Investigators: Principal Investigator: Robert E Goode, Campbell University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: March 4, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Waterborne Diseases
• Other Study ID Numbers: CUIRBRG273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No