Clinical trial NCT03060746: Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects
Official title: Helicobacter Pylori Sample Collection Protocol PRE-THERAPY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Gastric Ulcer
Nausea
Abdominal Pain
Weight Loss
Stomach Ulcer
Loss of Appetite
Bloating
Lead sponsor: DiaSorin Inc.
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2017-02-23
Enrollment: 277
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing EGD with biopsy for H. pylori diagnosis

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Helicobacter pylori Stool Collection
timeFrame: Through Study Completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: One (1) Location in Arizonia
state: Arizona
city: Mission Hills
country: United States
facility: One (1) Location in Mission Hills, California
state: California
city: Oxnard
country: United States
facility: One (1) Location in Oxnard, California
state: California
city: Palm Harbor
country: United States
facility: One (1) Location in Florida
state: Florida
city: Saint Louis
country: United States
facility: One (1) Location in Missouri
state: Missouri
city: Great Neck
country: United States
facility: One (1) Location in Great Neck, New York
state: New York
city: Asheville
country: United States
facility: One (1) Location in North Carolina
state: North Carolina
city: Mentor
country: United States
facility: One (1) Location in Ohio
state: Ohio
city: Greenville
country: United States
facility: One (1) Location in Greenville, South Carolina
state: South Carolina
city: Houston
country: United States
facility: One (1) Location in Houston, Texas
state: Texas
city: Chesapeake
country: United States
facility: One (1) Location in Virginia
state: Virginia
city: Bologna
country: Italy
facility: One (1) Location in Bologna, Italy
Study officials:
References: