- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309396
Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study) (AIRE)
March 20, 2024 updated by: Johns Hopkins University
Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Non-immune Mediated Food Sensitivities (AIRE Study)
Small intestinal bacterial overgrowth (SIBO) is defined as a condition in which an abnormally high amount of coliform bacteria is present in the small bowel and results in premature anaerobic fermentation of carbohydrates before reaching the colon.
Commonly recognized causes include gastric achlorhydria, post-surgical bowel stasis, gastrocolic/coloenteric fistulas, and motility disorders leading to bowel stasis..
The current "gold standard" for the diagnosis of SIBO, is a breath test that measures the concentration of hydrogen in response to lactulose, a carbohydrate that is only metabolized by bacteria.
However, its accuracy is only about 50% and therefore it is not a very useful test, leading most physicians to treat these patients empirically based on clinical suspicion alone.
The purpose of this study is to evaluate the clinical utility of a portable medical device called AIRE, an over-the-counter, commercially available handheld breath analyzer that measures exhaled hydrogen content.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Small intestinal bacterial overgrowth (SIBO) is defined as a condition in which an abnormally high amount of coliform bacteria is present in the small bowel and results in premature anaerobic fermentation of carbohydrates before reaching the colon.
Commonly recognized causes include gastric achlorhydria (i.e.
due to longstanding proton pump inhibitor (PPI) use), post-surgical bowel stasis, and gastrointestinal motility disorders leading to bowel stasis.
Although SIBO is commonly suspected, a major limitation in the field is the lack of a highly accurate test for SIBO.
The current gold standard relies on the demonstration of an early rise in breath hydrogen concentration in response to an orally ingested carbohydrate (commonly, lactulose) but its accuracy is about 50%.
This may be because it is a one-time snapshot with an artificial substrate.
Further, it has to be performed in a clinic, takes up to 5 hours and is relatively expensive.
The purpose of this study is to evaluate the clinical utility of a portable medical device called AIRE, which is a validated and commercially available handheld breathalyzer that measures hydrogen content in the breath and connects via Bluetooth to an associated smartphone application to provide immediate results and visual feedback after use.
H2 concentrations determined by the AIRE device showed significant correlation with those measured by LHBT.
The AIRE device therefore provides an alternative way to measure exhaled H2 that has the potential for addressing many of the limitations of the standard breath test.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guillermo Barahona, MD
- Phone Number: 4105508871
- Email: gbaraho1@jhmi.edu
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults (18 years of age or older)
- Chronic (>3 months) GI symptoms such as nausea, bloating, distention, altered bowel movements, weight loss or abdominal pain with no structural cause other than scleroderma.
- Clinical diagnosis of SIBO by patient's gastroenterologist with plans to obtain a lactulose hydrogen breath test.
- Ability to tolerate oral intake.
- Ability to undergo the LHBT.
- Access to a smartphone with Bluetooth capability
Exclusion Criteria:
- History of current or recent antibiotic use within the last 30 days
- History of inflammatory bowel disease
- Currently following a restrictive diet (for example low Fermentable Oligo-, Di-, Mono-saccharides And Polyols (FODMAP) diet)
- Unable to tolerate oral intake
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breath analyzer
Candidates who, after the screening period are eligible to receive the AIRE device.
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Eligible participants will eat participants' normal, typical diets during the first week of the study.
Participants will use the AIRE machine to measure exhaled H2 content before and after two meals each day - the first meal of the day and the last meal of the day.
Participants will breathe into the AIRE machine before eating to obtain a baseline value.
Once participants have finished eating, participants will breathe into the AIRE machine 30 minutes, 60 minutes, and 90 minutes postprandially.
The participants will record participants' food intake and symptoms directly into participants' smartphone via an app that comes with the AIRE device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hydrogen content in parts per million (ppm)
Time Frame: Baseline (1 week)
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Exhaled hydrogen (H2) content as measured over a 1-week period by AIRE on the patient's usual diet at home and the results of the standardized lactulose hydrogen breath test (LHBT) performed in the clinic.
Baseline hydrogen content is measured with AIRE device (study intervention) and LHBT (standard of care).
Only test with AIRE will be reported.
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Baseline (1 week)
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Hydrogen content in parts per million (ppm)
Time Frame: At 2 weeks after antibiotic treatment for positive LHBT
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For participants who have a positive LHBT test at baseline, antibiotics are prescribed as part of standard of care.
These participants will have a repeat AIRE test at 2 weeks post antibiotic treatment.
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At 2 weeks after antibiotic treatment for positive LHBT
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Hydrogen content in parts per million (ppm)
Time Frame: At one month after negative LHBT
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For participants who have a negative LHBT test at baseline, a repeat AIRE test is done at 1 month after baseline test.
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At one month after negative LHBT
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Glenn Treisman, MD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Estimated)
October 30, 2025
Study Completion (Estimated)
October 30, 2025
Study Registration Dates
First Submitted
March 12, 2020
First Submitted That Met QC Criteria
March 12, 2020
First Posted (Actual)
March 16, 2020
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00204104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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