Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

• Sponsor: DiaSorin Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03060733
• Collaborator: ICON Clinical Research (Industry)
• Enrollment: 13
• Locations: 5
• Actual Duration (Months): 14.9
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection; Gastric Ulcer; Nausea; Abdominal Pain; Weight Loss; Stomach Ulcer; Loss of Appetite; Bloating	Other: Post-Therapy

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 13 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Helicobacter Pylori Sample Collection Protocol POST-THERAPY
• Actual Study Start Date: Feb 14, 2017
• Actual Primary Completion Date: May 14, 2018
• Actual Study Completion Date: May 14, 2018

Outcome Measures

Primary Outcome Measures

1. Helicobacter pylori Stool Collection [Through Study Completion, an average of 1 year]

   In vitro diagnostic (IVD) device performance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	One (1) Location in California	Mission Hills	California	United States	91345
2	One (1) Location in Great Neck, New York	Great Neck	New York	United States	11023
3	One (1) Location in Ohio	Mentor	Ohio	United States	44060
4	One (1) Location in Houston, Texas	Houston	Texas	United States	77030
5	One (1) Location in Bologna, Italy	Bologna		Italy

Sponsors and Collaborators

• DiaSorin Inc.
• ICON Clinical Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DiaSorin Inc.
• ClinicalTrials.gov Identifier: NCT03060733
• Other Study ID Numbers: POST-TREAT Z001
• First Posted: Feb 23, 2017
• Last Update Posted: Feb 7, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Stomach Ulcer; Ulcer; Weight Loss; Abdominal Pain; Anorexia

Study Results

No Results Posted as of Feb 7, 2019