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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02905825
Recruitment Status : Completed
First Posted : September 19, 2016
Results First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

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

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Device: BreathID® Hp System Drug: BreathID® Hp Lab System Diagnostic Test: Stool Test Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Masking: None (Open Label)
Masking Description: The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 18, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : November 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Indication for Helicobacter pylori testing
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
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.
Other Name: Stool Antigen Test




Primary Outcome Measures :
  1. Number of Participants With Reported Adverse Events [ Time Frame: 24 hours ]
    Number of participants with reported adverse events after performing urea breath test


Secondary Outcome Measures :
  1. Percentage of Agreement [ Time Frame: 1 week ]
    Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection

  2. Percentage of Agreement [ Time Frame: 1 week ]
    Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02905825


Locations
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United States, Louisiana
Willis-Knighton Pediatric GI Specialist/Willis-Knighton Physician Network
Shreveport, Louisiana, United States, 71118
United States, Mississippi
Gastrointestinal Associates
Flowood, Mississippi, United States, 39232
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 10238
United States, Texas
Children's Health - Children's Medical Center Dallas (UT Southwestern)
Dallas, Texas, United States, 75235
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77094
Israel
Assaf Harofe Medical Center
Tzrifin, Israel, 70300
Sponsors and Collaborators
Exalenz Bioscience LTD.
  Study Documents (Full-Text)

Documents provided by Exalenz Bioscience LTD.:

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Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02905825     History of Changes
Other Study ID Numbers: PED-HP-0616B
First Posted: September 19, 2016    Key Record Dates
Results First Posted: July 4, 2018
Last Update Posted: July 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No