Water-Related DiseasesNCT03074760
A Study of Acequias Contamination & Association of Infectious Diseases in Peru
An observational study of Water-Related Diseases, run by BioRed LLC at 5 sites in Peru.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Water-Related Diseases
- What is being tested?
- Adenovirus, Rotavirus and H. pylori
- How many people
- 450 participants
- Where
- 5 sitesPeru
- Study dates
- 16 Mar 2017to 1 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Currently taking antiviral or antimicrobial medication
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Peru5 sites, 5 recruiting
- Recruiting
BioRed
Hacienda Pucala, Lambayeque
Lozado Dominguez
- Recruiting
BioRed
Pátapo, Lambayeque
Lozado Dominguez
- Recruiting
BioRed
Pimentel, Lambayeque
Lozado Dominguez
- Recruiting
BioRed
Pomalca, Lambayeque
Lozado Dominguez
- Recruiting
BioRed
Tumán, Lambayeque
Lozado Dominguez
About this study
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.
- Conditions
- Water-Related Diseases
- Being tested
- Adenovirus, Rotavirus, H. pylori
- Medical subject headings
- Waterborne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenovirusDiagnostic test
Diagnostic test for the presence of the adenovirus in the population groups
RotavirusDiagnostic test
Diagnostic test for the presence of the Rotavirus in the population groups
H. pyloriDiagnostic test
Diagnostic test for the presence of H. pylori infection in the population groups
| Study group | Role | What they receive |
|---|---|---|
| Contaminated acequias | Not described Receives: Diagnostic Test: Adenovirus; Diagnostic Test: Rotavirus; Diagnostic Test: H. pylori | |
| Non-contaminated acequias | Not described Receives: Diagnostic Test: Adenovirus; Diagnostic Test: Rotavirus; Diagnostic Test: H. pylori |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contamination of acequias
Presence of Fecal Coliforms in the acequias
Measured: March 20th - April 1st
Secondary outcomes (1)
Proportion of population with infections
Proportion of populations with adenovirus, rotavirus and H. pylori infections
Measured: March 20th - May 1st
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start16 Mar 2017
- Primary completion1 May 2017 (estimated)
- Study completion1 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water-Related DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioRed LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert E Goode, Principal investigator, Campbell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074760
- Sponsor's protocol ID
- CUIRBRG273
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Acequias Contamination & Association of Infectious Diseases in Peru
- ClinicalTrials.gov ID
- NCT03074760
- Acronym / sponsor ID
- CUIRBRG273
- Conditions
- Water-Related Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- BioRed LLCUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 1 May 2017 (estimated)
- Study completion
- 1 May 2017 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contaminated acequias | – | Diagnostic Test: Adenovirus, Diagnostic Test: Rotavirus, Diagnostic Test: H. pylori |
| Non-contaminated acequias | – | Diagnostic Test: Adenovirus, Diagnostic Test: Rotavirus, Diagnostic Test: H. pylori |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Currently taking antiviral or antimicrobial medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenovirusDiagnostic test for the presence of the adenovirus in the population groups | Diagnostic test | Contaminated acequias, Non-contaminated acequias |
| RotavirusDiagnostic test for the presence of the Rotavirus in the population groups | Diagnostic test | Contaminated acequias, Non-contaminated acequias |
| H. pyloriDiagnostic test for the presence of H. pylori infection in the population groups | Diagnostic test | Contaminated acequias, Non-contaminated acequias |
Primary outcome
Contamination of acequias
Time frame: March 20th - April 1st
Presence of Fecal Coliforms in the acequias
1 secondary outcome
Proportion of population with infections
Time frame: March 20th - May 1st
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E Goode principal investigator
Campbell University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Water-Related Diseases, run by BioRed LLC at 5 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Goode (919-672-2212, regoode0630@email.campbell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contamination of acequias (time frame: March 20th - April 1st). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.