Helicobacter InfectionsNCT02970110
Specimen Collection Study for H. Pylori Testing
An observational study of Helicobacter Infections, run by Biomerica at 4 sites in United States.
Trial summary
The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Helicobacter Infections
- How many people
- 98 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Feb 2017to 1 Mar 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of subjects scheduled for routine upper endoscopy for upper gastrointestinal tract symptoms such as dyspepsia. All prospective subjects must be off of proton-pump inhibitors, antibiotics, and bismuth for at least 2 weeks prior to submission of the stool specimen and undergoing endoscopy.
Who may be able to join
- Aged 21 and to 75 years.
- Able to read, speak, and understand English or have access to a translator in subject's native language.
- Patients without prior H. pylori eradication treatment.
- Currently not on proton pump inhibitors, antibiotics or bismuth
- Discontinuation at least 2 weeks prior to endoscopy and specimen collection.
- Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain]
- Undergo gastric biopsies as part of routine care
- Physician able to provide histology and rapid urease result on biopsy specimens.
Who cannot join
- Aged less than 21 years old or older than 75 years
- Unable to provide consent.
- Patients with a history of prior H. pylori eradication therapy.
- Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue
- Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y.
- Any unstable or poorly-controlled medical or psychiatric condition.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Southern California
Los Angeles, California, 90033
Medley Research Associates
Medley, Florida, 33166
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1610
Del Sol Research Management, Inc.
Tucson, Arizona, 85712
About this study
Official title: Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia
The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.
Read the detailed description
This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).
- Conditions
- Helicobacter Infections
- Medical subject headings
- Helicobacter Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive collection procedure
This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start27 Feb 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomerica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James R Buxbaum, M.D., Principal investigator, University of Southern California, Los Angeles County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970110
- Sponsor's protocol ID
- HPY-COL-001
- Status last verified
- Mar 2022
- First submitted
- 17 Nov 2016
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Demographics including age, gender, geographical location, histology and RUT results collected in this study will be shared with researchers involved with a future evaluation of an in vitro diagnostic device product in development at Biomerica.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia
- ClinicalTrials.gov ID
- NCT02970110
- Acronym / sponsor ID
- HPY-COL-001
- Conditions
- Helicobacter Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- BiomericaIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 21 Nov 2016 (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 acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.
Detailed description
This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of subjects scheduled for routine upper endoscopy for upper gastrointestinal tract symptoms such as dyspepsia. All prospective subjects must be off of proton-pump inhibitors, antibiotics, and bismuth for at least 2 weeks prior to submission of the stool specimen and undergoing endoscopy.
Key inclusion criteria (8 listed)
- Aged 21 and to 75 years.
- Able to read, speak, and understand English or have access to a translator in subject's native language.
- Patients without prior H. pylori eradication treatment.
- Currently not on proton pump inhibitors, antibiotics or bismuth
- Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain]
Key exclusion criteria (6 listed)
- Aged less than 21 years old or older than 75 years
- Unable to provide consent.
- Patients with a history of prior H. pylori eradication therapy.
- Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue
- Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y.
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
Non-invasive collection procedure
Time frame: 1 year
This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics.
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 18 Mar 2022.
- Individual participant dataSharing planned: No. Demographics including age, gender, geographical location, histology and RUT results collected in this study will be shared with researchers involved with a future evaluation of an in vitro diagnostic device product in development at Biomerica.
Related trials for Helicobacter Infections
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Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
HELICOBACTER PYLORI INFECTIONS
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Efficacy Comparison of 10-Day High-Dose Versus 14-Day Standard-Dose Vonoprazan Plus Amoxicillin in Helicobacter Pylori Eradication: A Multicenter Non-Inferiority Randomized Controlled Trial
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Prevalence of Helicobacter Pylori Infection
Residents of Palau Aged 18 Years or Older
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.
James R Buxbaum, M.D. principal investigator
University of Southern California, Los Angeles County Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Infections, run by Biomerica at 4 sites in United States.
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 8 inclusion and 6 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Non-invasive collection procedure (time frame: 1 year). 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 18 Mar 2022.