ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 10 for:    Recruiting, Not yet recruiting, Available Studies | "Stomach Ulcer"

Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03060733
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
DiaSorin Inc.

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
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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Helicobacter Pylori Sample Collection Protocol POST-THERAPY
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

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


Primary Outcome Measures :
  1. Helicobacter pylori Stool Collection [ Time Frame: Through Study Completion, an average of 1 year ]
    In vitro diagnostic (IVD) device performance


Biospecimen Retention:   Samples Without DNA
Human Stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060733


Contacts
Contact: Clinical DiaSorin.com 651-439-9710 Clinical@diasorin.com

Locations
United States, California
One (1) Location in California Recruiting
Mission Hills, California, United States, 91345
United States, Missouri
One (1) Location in Missouri Withdrawn
Saint Louis, Missouri, United States, 63141
United States, New York
One (1) Location in Great Neck, New York Recruiting
Great Neck, New York, United States, 11023
United States, Ohio
One (1) Location in Ohio Recruiting
Mentor, Ohio, United States, 44060
United States, Texas
One (1) Location in Houston, Texas Recruiting
Houston, Texas, United States, 77030
Italy
One (1) Location in Bologna, Italy Recruiting
Bologna, Italy
Sponsors and Collaborators
DiaSorin Inc.
ICON Clinical Research

Responsible Party: DiaSorin Inc.
ClinicalTrials.gov Identifier: NCT03060733     History of Changes
Other Study ID Numbers: POST-TREAT Z001
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
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
Helicobacter Infections
Anorexia
Pathologic Processes
Body Weight Changes
Body Weight
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms, Digestive
Gram-Negative Bacterial Infections
Bacterial Infections
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases