Specimen Collection Study for H. Pylori Testing

Completed

Conditions studied: Helicobacter Infections

In brief

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.

Key facts

Study ID: NCT02970110
Run by: Biomerica
People needed: 98
Starts: 2017-02-27
Expected to finish: 2020-03-01
Last updated by the study team: 2022-03-18

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Del Sol Research Management, Inc. — Tucson, Arizona, United States
University of Southern California — Los Angeles, California, United States
Medley Research Associates — Medley, Florida, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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