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

Helicobacter Pylori Infection Clinical Trial

Official title:

Clinical Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905825
• Other study ID #: PED-HP-0616B
• Status: Completed
• Phase: Phase 3
• Start date: May 18, 2017
• Est. completion date: November 5, 2017

Study information

• Verified date: June 2018
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 5, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Device:
• BreathID® Hp System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Drug:
• BreathID® Hp Lab System
Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea

Diagnostic Test:
• Stool Test
Each subject was asked to perform a stool test in parallel to the breath test.

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Tzrifin
United States	Children's Health - Children's Medical Center Dallas (UT Southwestern)	Dallas	Texas
United States	Gastrointestinal Associates	Flowood	Mississippi
United States	Baylor College of Medicine/Texas Children's Hospital	Houston	Texas
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Reported Adverse Events	Number of participants with reported adverse events after performing urea breath test	24 hours
Secondary	Percentage of Agreement	Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection	1 week
Secondary	Percentage of Agreement	Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection	1 week