Helicobacter Pylori InfectionNCT03060746
Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects
An observational study of Helicobacter Pylori Infection and Gastric Ulcer, run by DiaSorin Inc. at 12 sites in 2 countries.
Trial summary
The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Helicobacter Pylori Infection, Gastric Ulcer, Nausea
- What is being tested?
- Newly Diagnosed
- How many people
- 277 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 14 Feb 2017to 3 May 2018
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing EGD with biopsy for H. pylori diagnosis
Who may be able to join
- Adult ≥ 22 years, either gender
- Subject is symptomatic showing signs and symptoms of gastritis
- Subject is not under evaluation for post-therapy follow up diagnosis
- Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing
- Biopsy is obtained from antrum and/or corpus and is tested by CRM
- At least two of the three CRM tests are performed
- Subject whose EGD with biopsy procedure occurred ≤ 7 days prior to stool collection
- Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B
Who cannot join
- Any subject that does not meet the inclusion criteria
- Subject with current severe H. pylori infection
- Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection
- Subject recently tested, less than 3 months and knowledge of H. pylori absence
- Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment
- Pregnant or lactating
- Inability or unwilling to perform required study procedures
- Subject is unable or unwilling to provide informed consent
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
One (1) Location in North Carolina
Asheville, North Carolina, 28801
One (1) Location in Virginia
Chesapeake, Virginia, 23320
One (1) Location in Great Neck, New York
Great Neck, New York, 11023
One (1) Location in Greenville, South Carolina
Greenville, South Carolina, 29615
One (1) Location in Houston, Texas
Houston, Texas, 77030
One (1) Location in Ohio
Mentor, Ohio, 44060
One (1) Location in Arizonia
Mesa, Arizona, 85206
One (1) Location in Mission Hills, California
Mission Hills, California, 91345
One (1) Location in Oxnard, California
Oxnard, California, 93030
One (1) Location in Florida
Palm Harbor, Florida, 34684
One (1) Location in Missouri
St Louis, Missouri, 63141
About this study
Official title: Helicobacter Pylori Sample Collection Protocol PRE-THERAPY
The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
Read the detailed description
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.
- Conditions
- Helicobacter Pylori Infection, Gastric Ulcer, Nausea, Abdominal Pain, Weight Loss, Stomach Ulcer
- Being tested
- Newly Diagnosed
- Medical subject headings
- Stomach Ulcer, Nausea, Abdominal Pain, Weight Loss, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newly DiagnosedOther
Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori Stool Collection
In vitro diagnostic (IVD) device performance
Measured: Through Study Completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start14 Feb 2017
- Primary completion3 May 2018
- Study completion3 May 2018
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.
- 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
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiaSorin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060746
- Sponsor's protocol ID
- PRE-TREAT A001
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2017
- Last updated
- 30 Dec 2021
- 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 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Sample Collection Protocol PRE-THERAPY
- ClinicalTrials.gov ID
- NCT03060746
- Acronym / sponsor ID
- PRE-TREAT A001
- Conditions
- Helicobacter Pylori Infection, Gastric Ulcer, Nausea, Abdominal Pain, Weight Loss, Stomach Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- DiaSorin Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 23 Feb 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.
The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
Detailed description
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing EGD with biopsy for H. pylori diagnosis
Key inclusion criteria (8 listed)
- Adult ≥ 22 years, either gender
- Subject is symptomatic showing signs and symptoms of gastritis
- Subject is not under evaluation for post-therapy follow up diagnosis
- Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing
- Biopsy is obtained from antrum and/or corpus and is tested by CRM
Key exclusion criteria (8 listed)
- Any subject that does not meet the inclusion criteria
- Subject with current severe H. pylori infection
- Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection
- Subject recently tested, less than 3 months and knowledge of H. pylori absence
- Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment
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 |
|---|---|---|
| Newly DiagnosedGastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample | Other | – |
Primary outcome
Helicobacter pylori Stool Collection
Time frame: Through Study Completion, an average of 1 year
In vitro diagnostic (IVD) device performance
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 30 Dec 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Gastric Ulcer, run by DiaSorin Inc. at 12 sites in 2 countries.
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 8 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Italy. 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?
Helicobacter pylori Stool Collection (time frame: Through Study Completion, an average of 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 30 Dec 2021.