Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects
Completed
Conditions studied: Helicobacter Pylori Infection, Gastric Ulcer, Nausea, Abdominal Pain, Weight Loss, Stomach Ulcer, Loss of Appetite, Bloating
In brief
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.
Key facts
- Study ID
- NCT03060733
- Run by
- DiaSorin Inc.
- People needed
- 13
- Starts
- 2017-02-14
- Expected to finish
- 2018-05-14
- Last updated by the study team
- 2019-02-07
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- One (1) Location in California — Mission Hills, California, United States
- One (1) Location in Great Neck, New York — Great Neck, New York, United States
- One (1) Location in Ohio — Mentor, Ohio, United States
- One (1) Location in Houston, Texas — Houston, Texas, United States
- One (1) Location in Bologna, Italy — Bologna, Italy
Full record on ClinicalTrials.gov
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