SIBOAIRENCT04309396
Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study)
A study testing Hydrogen content recording in people with SIBO and Small Bowel Bacterial Overgrowth Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SIBO, Small Bowel Bacterial Overgrowth Syndrome
- What is being tested?
- Hydrogen content recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: 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.
Read the 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.
- Conditions
- SIBO, Small Bowel Bacterial Overgrowth Syndrome
- Being tested
- Hydrogen content recording
- Keywords
- SIBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen content recordingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Breath analyzer | Experimental | Candidates who, after the screening period are eligible to receive the AIRE device. Receives: Device: Hydrogen content recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrogen Content in Parts Per Million (Ppm)
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.
Measured: Up to 1 week
Hydrogen Content in Parts Per Million (Ppm)
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.
Measured: 2 weeks after antibiotic treatment for positive LHBT
Hydrogen Content in Parts Per Million (Ppm)
For participants who have a negative LHBT test at baseline, a repeat AIRE test is done at 1 month after baseline test.
Measured: One month after negative LHBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Oct 2020
- Primary completion10 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SIBOStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- FoodMarble
- Responsible party
- Sponsor
- Investigators
- Glenn Treisman, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309396
- Sponsor's protocol ID
- IRB00204104
- Acronym
- AIRE
- Status last verified
- May 2025
- First submitted
- 12 Mar 2020
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Non-immune Mediated Food Sensitivities (AIRE Study)
- ClinicalTrials.gov ID
- NCT04309396
- Acronym / sponsor ID
- AIRE / IRB00204104
- Conditions
- SIBO, Small Bowel Bacterial Overgrowth Syndrome
- Keywords
- SIBO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- FoodMarble
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Posted 28 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breath analyzer | Experimental | Device: Hydrogen content recordingCandidates who, after the screening period are eligible to receive the AIRE device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen content recordingEligible 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. | Device | Breath analyzer |
Primary outcome
Hydrogen Content in Parts Per Million (Ppm)
Time frame: 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.
Hydrogen Content in Parts Per Million (Ppm)
Time frame: 2 weeks after antibiotic treatment for positive LHBT
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.
Hydrogen Content in Parts Per Million (Ppm)
Time frame: One month after negative LHBT
For participants who have a negative LHBT test at baseline, a repeat AIRE test is done at 1 month after baseline test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for SIBO
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
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RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
Periodontitis (Stage 3), Periodontitis Stage IV
Enrolling by invitationPhase 2
Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
RecruitingObservational study
Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC)
Pancreatic Adenocarcinoma, Weight Loss
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Treisman, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen content recording in people with SIBO and Small Bowel Bacterial Overgrowth Syndrome, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydrogen Content in Parts Per Million (Ppm) (time frame: Up to 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.