Trial Outcomes & Findings for Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study) (NCT NCT04309396)

Results Overview

Exhaled hydrogen (H2) content as measured over a 1-week period by AIRE on the patient's usual diet at home. Mean of one week readings is reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Up to 1 week

Results posted on

2025-05-28

Participant Flow

45 participants were enrolled, however 2 patients withdrew for the study before randomization.

Participant milestones

Participant milestones
Measure	Breath Analyzer Candidates who, after the screening period are eligible to receive the AIRE device. Hydrogen content recording: 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.
Overall Study STARTED	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breath Analyzer n=43 Participants Candidates who, after the screening period are eligible to receive the AIRE device. Hydrogen content recording: 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.
Age, Categorical <=18 years	0 Participants n=43 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=43 Participants
Age, Categorical >=65 years	0 Participants n=43 Participants
Sex: Female, Male Female	36 Participants n=43 Participants
Sex: Female, Male Male	7 Participants n=43 Participants

PRIMARY outcome

Timeframe: Up to 1 week

Exhaled hydrogen (H2) content as measured over a 1-week period by AIRE on the patient's usual diet at home. Mean of one week readings is reported.

Outcome measures

Outcome measures
Measure	Breath Analyzer n=43 Participants Candidates who, after the screening period are eligible to receive the AIRE device. Hydrogen content recording: 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.
Hydrogen Content in Parts Per Million (Ppm)	3.5 ppm Standard Deviation 0.7

PRIMARY outcome

Timeframe: 2 weeks after antibiotic treatment for positive LHBT

Population: Only participants with positive LHBT test at baseline were analyzed.

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.

Outcome measures

Outcome measures
Measure	Breath Analyzer n=39 Participants Candidates who, after the screening period are eligible to receive the AIRE device. Hydrogen content recording: 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.
Hydrogen Content in Parts Per Million (Ppm)	10.7 ppm Standard Deviation 1.1

PRIMARY outcome

Timeframe: One month after negative LHBT

Population: Only Participants who had a negative LHBT test at baseline were analyzed

For participants who have a negative LHBT test at baseline, a repeat AIRE test is done at 1 month after baseline test.

Outcome measures

Outcome measures
Measure	Breath Analyzer n=4 Participants Candidates who, after the screening period are eligible to receive the AIRE device. Hydrogen content recording: 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.
Hydrogen Content in Parts Per Million (Ppm)	8.5 ppm Standard Deviation 3.1

Adverse Events

Breath Analyzer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jay Pasricha

Mayo Clinic Arizona

Phone: (480)301-4279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place