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CompletedNCT03060733Updated Feb 7, 2019

Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

An observational study in Helicobacter Pylori Infection, Gastric Ulcer and Nausea, sponsored by DiaSorin Inc.. Completed at 5 sites in 2 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by DiaSorin Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
13
Ages
22 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Helicobacter Pylori Infection
  • Gastric Ulcer
  • Nausea
  • Abdominal Pain
  • Weight Loss
  • Stomach Ulcer
  • Loss of Appetite
  • Bloating
03

In context

Stomach Ulcer

114 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's enrollment of 13 is below the median of 676 across 23 observational studies indexed under Stomach Ulcer.

Browse Stomach Ulcer studies →

Lead sponsor

DiaSorin Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherPost-Therapy

    Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample

06

What researchers measure

Primary outcomes

  1. Helicobacter pylori Stool Collection

    In vitro diagnostic (IVD) device performance

    Time frame: Through Study Completion, an average of 1 year

07

Study locations

5 sites
  • One (1) Location in California
    Mission Hills, California 91345, United States
  • One (1) Location in Great Neck, New York
    Great Neck, New York 11023, United States
  • One (1) Location in Ohio
    Mentor, Ohio 44060, United States
  • One (1) Location in Houston, Texas
    Houston, Texas 77030, United States
  • One (1) Location in Bologna, Italy
    Bologna, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in May 2018, 15 months.

Of 15 observational studies under Stomach Ulcer, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 50. This study's 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2017
First posted
Feb 23, 2017
StartActual
Feb 14, 2017
Primary completionActual
May 14, 2018
CompletionActual
May 14, 2018
Last update
Feb 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03060733
Lead sponsor
DiaSorin Inc.
Collaborators
ICON Clinical Research
Responsible party
Sponsor
First posted
Feb 23, 2017
Start date
Feb 14, 2017
Primary completion
May 14, 2018
Completion
May 14, 2018
Last update
Feb 7, 2019

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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DiaSorin Inc.

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