Helicobacter Pylori InfectionNCT03060733
Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects
An observational study of Helicobacter Pylori Infection and Gastric Ulcer, run by DiaSorin Inc. at 5 sites in 2 countries.
Trial summary
The primary objective is to obtain stool samples from post-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?
- Post-Therapy
- How many people
- 13 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 14 Feb 2017to 14 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 are evaluated for H. pylori infectious status prior to eligibility. Evaluation includes use of a diagnostic H. pylori test, such as, an FDA cleared UBT or an FDA cleared Fecal Stool Antigen. Infectious status must be determined positive for H. pylori for subject eligibility. Eligible subjects are undergoing EGD with biopsy for H. pylori infectious status after completion of therapy
Who may be able to join
- Adult ≥ 22 years, either gender
- Subject previously diagnosed with H. pylori infection
- Subject received and completed FDA approved treatment option
- Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment option
- Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared Fecal Antigen Test
- Subject will undergo EGD and gastric biopsy as part of routine care to measure H. pylori post-therapy response
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- 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 occurred ≤ 7 days prior to stool collection
- Willing and able to sign the IRB approved Informed Consent form for this study project
Who cannot join
- Subject with current severe H. pylori infection
- Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4 weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors prior to collection
- Pregnant or lactating
- Inability or unwilling to perform required study procedures
- Subject is unable or unwilling to provide informed consent
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
One (1) Location in Great Neck, New York
Great Neck, New York, 11023
One (1) Location in Houston, Texas
Houston, Texas, 77030
One (1) Location in Ohio
Mentor, Ohio, 44060
One (1) Location in California
Mission Hills, California, 91345
About this study
Official title: Helicobacter Pylori Sample Collection Protocol POST-THERAPY
The primary objective is to obtain stool samples from post-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
- Post-Therapy
- 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.
Post-TherapyOther
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 completion14 May 2018
- Study completion14 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
- 13 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
- NCT03060733
- Sponsor's protocol ID
- POST-TREAT Z001
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2017
- Last updated
- 7 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Sample Collection Protocol POST-THERAPY
- ClinicalTrials.gov ID
- NCT03060733
- Acronym / sponsor ID
- POST-TREAT Z001
- Conditions
- Helicobacter Pylori Infection, Gastric Ulcer, Nausea, Abdominal Pain, Weight Loss, Stomach Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- DiaSorin Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 14 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 post-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 are evaluated for H. pylori infectious status prior to eligibility. Evaluation includes use of a diagnostic H. pylori test, such as, an FDA cleared UBT or an FDA cleared Fecal Stool Antigen. Infectious status must be determined positive for H. pylori for subject eligibility. Eligible subjects are undergoing EGD with biopsy for H. pylori infectious status after completion of therapy
Key inclusion criteria (10 listed)
- Adult ≥ 22 years, either gender
- Subject previously diagnosed with H. pylori infection
- Subject received and completed FDA approved treatment option
- Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment option
- Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared Fecal Antigen Test
Key exclusion criteria (5 listed)
- Subject with current severe H. pylori infection
- Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4 weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors prior to collection
- Pregnant or lactating
- Inability or unwilling to perform required study procedures
- Subject is unable or unwilling to provide informed consent
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 |
|---|---|---|
| Post-TherapyGastric 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 7 Feb 2019.
- 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.
5 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 5 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 10 inclusion and 5 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 7 Feb 2019. 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 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 7 Feb 2019.