Clinical trial NCT03060733: Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects
Official title: Helicobacter Pylori Sample Collection Protocol POST-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: 13
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 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

Brief 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.

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 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:

* 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

Primary outcomes:
measure: Helicobacter pylori Stool Collection
timeFrame: Through Study Completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Hills
country: United States
facility: One (1) Location in California
state: California
city: Great Neck
country: United States
facility: One (1) Location in Great Neck, New York
state: New York
city: Mentor
country: United States
facility: One (1) Location in Ohio
state: Ohio
city: Houston
country: United States
facility: One (1) Location in Houston, Texas
state: Texas
city: Bologna
country: Italy
facility: One (1) Location in Bologna, Italy
Study officials:
References: