Clinical trial NCT02970110: Specimen Collection Study for H. Pylori Testing
Official title: Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Infections
Lead sponsor: Biomerica
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of subjects scheduled for routine upper endoscopy for upper gastrointestinal tract symptoms such as dyspepsia. All prospective subjects must be off of proton-pump inhibitors, antibiotics, and bismuth for at least 2 weeks prior to submission of the stool specimen and undergoing endoscopy.

Brief summary: The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.

Detailed description: This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).

Eligibility criteria: Inclusion Criteria:

* Aged 21 and to 75 years.
* Able to read, speak, and understand English or have access to a translator in subject's native language.
* Patients without prior H. pylori eradication treatment.
* Currently not on proton pump inhibitors, antibiotics or bismuth

  * Discontinuation at least 2 weeks prior to endoscopy and specimen collection.
* Present with signs and symptoms of dyspepsia \[e.g. upper abdominal discomfort or pain\]
* Undergo gastric biopsies as part of routine care
* Physician able to provide histology and rapid urease result on biopsy specimens.

Exclusion Criteria:

* Aged less than 21 years old or older than 75 years
* Unable to provide consent.
* Patients with a history of prior H. pylori eradication therapy.
* Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue
* Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y.
* Any unstable or poorly-controlled medical or psychiatric condition.

Primary outcomes:
measure: Non-invasive collection procedure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Del Sol Research Management, Inc.
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Medley
country: United States
facility: Medley Research Associates
state: Florida
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: University of Southern California, Los Angeles County Hospital
name: James R Buxbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References: