Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

NCT03060733 | Completed

• 1 other identifier: POST-TREAT Z001
• Study Type: observational
• Target: 13
• Locations: 2 countries
• Sites: 5

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.

Conditions

Helicobacter Pylori Infection; Gastric Ulcer; Nausea; Abdominal Pain; Weight Loss; Stomach Ulcer; Loss of Appetite; Bloating

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori Stool Collection

  In vitro diagnostic (IVD) device performance

  Through Study Completion, an average of 1 year

Interventions

Post-Therapy OTHER

Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are evaluated for H. pylori infectious status prior to eligibility. Evaluation includes use of a diagnostic H. pylori test, such as, an FDA cleared UBT or an FDA cleared Fecal Stool Antigen. Infectious status must be determined positive for H. pylori for subject eligibility. Eligible subjects are undergoing EGD with biopsy for H. pylori infectious status after completion of therapy

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

Sponsors & Collaborators

• DiaSorin Inc.: lead
• ICON Clinical Research: collaborator

Study Sites (5)

One (1) Location in California

Mission Hills, California, 91345, United States

Location

One (1) Location in Great Neck, New York

Great Neck, New York, 11023, United States

Location

One (1) Location in Ohio

Mentor, Ohio, 44060, United States

Location

One (1) Location in Houston, Texas

Houston, Texas, 77030, United States

Location

One (1) Location in Bologna, Italy

Bologna, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human Stool

MeSH Terms

Conditions

Stomach Ulcer; Nausea; Abdominal Pain; Weight Loss; Anorexia

Interventions

Aftercare

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Body Weight Changes; Body Weight

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: February 14, 2017
• Primary Completion: May 14, 2018
• Study Completion: May 14, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

IT (1); US (4)