NCT03060746

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2018

Completed
Last Updated

December 30, 2021

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

February 15, 2017

Last Update Submit

December 10, 2021

Conditions

Helicobacter Pylori InfectionGastric UlcerNauseaAbdominal PainWeight LossStomach UlcerLoss of AppetiteBloating

Outcome Measures

Primary Outcomes (1)

  • Helicobacter pylori Stool Collection

    In vitro diagnostic (IVD) device performance

    Through Study Completion, an average of 1 year

Interventions

Newly DiagnosedOTHER

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

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing EGD with biopsy for H. pylori diagnosis

You may qualify if:

  • Adult ≥ 22 years, either gender
  • Subject is symptomatic showing signs and symptoms of gastritis
  • Subject is not under evaluation for post-therapy follow up diagnosis
  • Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing
  • 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 procedure occurred ≤ 7 days prior to stool collection
  • Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B

You may not qualify if:

  • Subject with current severe H. pylori infection
  • Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection
  • Subject recently tested, less than 3 months and knowledge of H. pylori absence
  • Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment
  • Pregnant or lactating
  • Inability or unwilling to perform required study procedures
  • Subject is unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

One (1) Location in Arizonia

Mesa, Arizona, 85206, United States

Location

One (1) Location in Mission Hills, California

Mission Hills, California, 91345, United States

Location

One (1) Location in Oxnard, California

Oxnard, California, 93030, United States

Location

One (1) Location in Florida

Palm Harbor, Florida, 34684, United States

Location

One (1) Location in Missouri

St Louis, Missouri, 63141, United States

Location

One (1) Location in Great Neck, New York

Great Neck, New York, 11023, United States

Location

One (1) Location in North Carolina

Asheville, North Carolina, 28801, United States

Location

One (1) Location in Ohio

Mentor, Ohio, 44060, United States

Location

One (1) Location in Greenville, South Carolina

Greenville, South Carolina, 29615, United States

Location

One (1) Location in Houston, Texas

Houston, Texas, 77030, United States

Location

One (1) Location in Virginia

Chesapeake, Virginia, 23320, United States

Location

One (1) Location in Bologna, Italy

Bologna, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human Stool

MeSH Terms

Conditions

Stomach UlcerNauseaAbdominal PainWeight LossAnorexia

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsBody Weight ChangesBody Weight

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 3, 2018

Study Completion

May 3, 2018

Last Updated

December 30, 2021

Record last verified: 2019-02

Locations

US(11)IT(1)