Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics

NCT02905825 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: PED-HP-0616B
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 6

Brief Summary

Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Reported Adverse Events

  Number of participants with reported adverse events after performing urea breath test

  24 hours

Secondary Outcomes (2)

• Percentage of Agreement

  1 week

• Percentage of Agreement

  1 week

Study Arms (1)

Indication for Helicobacter pylori testing

EXPERIMENTAL

Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.

Device: BreathID® Hp System; Drug: BreathID® Hp Lab System; Diagnostic Test: Stool Test

Interventions

BreathID® Hp System DEVICE

Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Indication for Helicobacter pylori testing

BreathID® Hp Lab System DRUG

Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Indication for Helicobacter pylori testing

Stool Test DIAGNOSTIC_TEST

Each subject was asked to perform a stool test in parallel to the breath test.

Also known as: Stool Antigen Test

Indication for Helicobacter pylori testing

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be older than 3 and younger than 18 years of age
• Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori)
• Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form
• Naïve to H. pylori treatment in the past 6 weeks

You may not qualify if:

• Participation in other interventional trials
• PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test
• Pregnant or breastfeeding female
• Allergy to test substrates
• Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test
• Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test.
• Exposure to any 13C-enriched substance 24 hours prior to the breath test.
• Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
• Subjects outside US - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (6)

Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network

Shreveport, Louisiana, 71118, United States

Location

Gastrointestinal Associates

Flowood, Mississippi, 39232, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 10238, United States

Location

Children's Health - Children's Medical Center Dallas (UT Southwestern)

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77094, United States

Location

Assaf Harofe Medical Center

Tzrifin, 70300, Israel

Location

MeSH Terms

Interventions

Occult Blood

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Avraham Hershkowitz
• Organization: Exalenz Bisocience

avrahamh@exalenz.com

972-8-9737513

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 19, 2016
• Study Start: May 18, 2017
• Primary Completion: October 30, 2017
• Study Completion: November 5, 2017
• Last Updated: December 20, 2022
• Results First Posted: July 5, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (5)