Trials / Completed
CompletedNCT03060746
Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects
Helicobacter Pylori Sample Collection Protocol PRE-THERAPY
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 277 (actual)
- Sponsor
- DiaSorin Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Helicobacter Pylori Infection
- Gastric Ulcer
- Nausea
- Abdominal Pain
- Weight Loss
- Stomach Ulcer
- Loss of Appetite
- Bloating
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Newly Diagnosed | Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample |
Timeline
- Start date
- 2017-02-14
- Primary completion
- 2018-05-03
- Completion
- 2018-05-03
- First posted
- 2017-02-23
- Last updated
- 2021-12-30
Locations
12 sites across 2 countries: United States, Italy
Source: ClinicalTrials.gov record NCT03060746. Inclusion in this directory is not an endorsement.