Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

Weight Loss Clinical Trial

Official title:

Helicobacter Pylori Sample Collection Protocol POST-THERAPY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060733
• Other study ID #: POST-TREAT Z001
• Status: Completed
• Start date: February 14, 2017
• Est. completion date: May 14, 2018

Study information

• Verified date: February 2019
• Source: DiaSorin Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 14, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Anorexia
• Bloating
• Gastric Ulcer
• Helicobacter Infections
• Helicobacter Pylori Infection
• Loss of Appetite
• Nausea
• Stomach Ulcer
• Ulcer
• Weight Loss

Intervention

Other:
• Post-Therapy
Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample

Locations

Country	Name	City	State
Italy	One (1) Location in Bologna, Italy	Bologna
United States	One (1) Location in Great Neck, New York	Great Neck	New York
United States	One (1) Location in Houston, Texas	Houston	Texas
United States	One (1) Location in Ohio	Mentor	Ohio
United States	One (1) Location in California	Mission Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
DiaSorin Inc.	ICON Clinical Research

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori Stool Collection	In vitro diagnostic (IVD) device performance	Through Study Completion, an average of 1 year