Helicobacter Pylori InfectionNCT01512875
S1119 Peruvian H. Pylori Water Contamination Study
An observational study of Helicobacter Pylori Infection, run by SWOG Cancer Research Network at 1 site in Peru.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- How many people
- 107 participants
- Where
- 1 sitePeru
- Study dates
- Dec 2011to Nov 2013
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Cancer and Helicobacter Pylori Infection in Lima, Peru: The Role of Water Contamination
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.
Read the detailed 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.
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, water contamination, Lima, Peru
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| biopsy proven H. pylori | Patient must have lived in the districts of Lima, Peru listed in the protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 1 year of receving last sample
Secondary outcomes (1)
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.
Measured: Within 1 year of receiving last sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- University of Michigan, Hope Foundation
- Responsible party
- Sponsor
- Investigators
- Manuel Valdivieso, M.D., Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512875
- Sponsor's protocol ID
- S1119
- Status last verified
- Nov 2015
- First submitted
- 13 Jan 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Cancer and Helicobacter Pylori Infection in Lima, Peru: The Role of Water Contamination
- ClinicalTrials.gov ID
- NCT01512875
- Acronym / sponsor ID
- S1119
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, water contamination, Lima, Peru
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- University of Michigan, Hope Foundation
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Jan 2012 (estimated)
- 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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biopsy proven H. pylori | – | –Patient must have lived in the districts of Lima, Peru listed in the protocol. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Correlation of H. pylori in water and those of stomachs of patients with symptoms
Time frame: Within 1 year of receiving last sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Manuel Valdivieso, M.D. principal investigator
SWOG Cancer Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by SWOG Cancer Research Network at 1 site 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 6 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: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect H. pylori in public drinking water of Lima Peru (time frame: within 1 year of receving last sample). 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 17 Nov 2015.