Hydrogen Breathalyzer for Small Intestinal Bacterial Overgrowth

(AIRE Trial)

Overseen By Guillermo Barahona, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Antibiotics, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called AIRE, which may help diagnose small intestinal bacterial overgrowth (SIBO). SIBO occurs when excessive bacteria grow in the small intestine, causing symptoms like bloating and stomach pain. Current tests for SIBO lack accuracy, so the trial aims to determine if AIRE, a handheld breath analyzer, can improve diagnosis by measuring hydrogen levels in the breath. Suitable candidates for this trial have experienced ongoing digestive issues for more than three months and have received a SIBO diagnosis from their doctor. Participants will need a smartphone with Bluetooth to use the device. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance SIBO diagnosis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used antibiotics in the last 30 days.

What prior data suggests that this device is safe for diagnosing SIBO?

Studies have shown that a hydrogen breath test safely checks for small intestinal bacterial overgrowth (SIBO). The AIRE device, a handheld breath analyzer, is available and widely used. It measures hydrogen in breath to help identify SIBO.

Research indicates that people generally find the AIRE device easy to use, with many safely performing tests at home. These studies report no harmful side effects, suggesting the device is safe for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Small Intestinal Bacterial Overgrowth (SIBO) involve antibiotics that target bacterial overgrowth directly. However, the AIRE device offers a different approach by using a hydrogen breathalyzer to help diagnose SIBO through breath analysis. Researchers are excited about this method because it provides a non-invasive, quick way to identify SIBO, potentially leading to faster and more accurate diagnosis. This could allow for more targeted treatment plans, improving patient outcomes and reducing unnecessary antibiotic use.

What evidence suggests that this breath analyzer is effective for diagnosing SIBO?

Studies have shown that the AIRE device, used by participants in this trial, can effectively measure hydrogen levels in breath, crucial for diagnosing small intestinal bacterial overgrowth (SIBO). Research indicates that the device's results align with other breath tests, such as lactulose and glucose tests, showing about a 33% positive detection rate. This handheld breath analyzer is easy to use and helps identify SIBO by detecting excess hydrogen, a sign of bacterial overgrowth. While traditional tests are accurate about 50% of the time, the AIRE device provides a practical, portable option for home testing. ^{6 7 8 9 10}

Who Is on the Research Team?

Glenn Treisman, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic gastrointestinal symptoms like nausea, bloating, or abdominal pain and a clinical diagnosis of SIBO. Participants must be able to eat normally and use a smartphone with Bluetooth. Those on recent antibiotics, with inflammatory bowel disease, or on restrictive diets cannot join.

Inclusion Criteria

Access to a smartphone with Bluetooth capability

I have had GI symptoms like nausea or bloating for over 3 months due to scleroderma.

I can undergo the lactose breath test.

Exclusion Criteria

I have a history of inflammatory bowel disease.

I have taken antibiotics in the last 30 days.

You are currently on a special diet, like a low FODMAP diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AIRE device to measure exhaled hydrogen content

1 month

1 visit (in-person) for device distribution

Follow-up

Participants are monitored for hydrogen content in parts per million (ppm) using the AIRE device

1 month

1 visit (virtual) for data collection

What Are the Treatments Tested in This Trial?

Interventions

• AIRE

Trial Overview The study tests the AIRE device, a handheld breath analyzer that measures hydrogen in breath to identify food sensitivities related to SIBO. It aims to see if this portable device can more accurately detect SIBO compared to current standard methods.

How Is the Trial Designed?

Group I: Breath analyzer Experimental Treatment 1 Intervention

Candidates who, after the screening period are eligible to receive the AIRE device.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

FoodMarble

Collaborator

Trials

1

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11602852/

Validation of a Hand-Held Point-of-Care Device to Measure ... This study aimed to evaluate the utility of a portable, point-of-care breath analysis device (AIRE®, FoodMarble) in patients suspected to have SIBO.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/96/NCT04309396/Prot_SAP_ICF_000.pdf

May 31 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 ...

3. medrxiv.org medrxiv.org/content/10.1101/2022.04.21.22274143v1.full-text

Improving the Diagnosis of SIBO Using an At-Home ... The overall positive yield for the LHBTs performed using AIRE (33%) was comparable to that reported elsewhere for both lactulose and glucose ...

4. withpower.com withpower.com/trial/phase-blind-loop-syndrome-9-2020-27e61

Hydrogen Breathalyzer for Small Intestinal Bacterial ... This trial is testing a handheld device called AIRE that measures hydrogen in the breath to diagnose SIBO. It is aimed at patients suspected of having SIBO ...

5. trials.foodallergy.org trials.foodallergy.org/trials/NCT04309396

Clinical Utility of Handheld Hydrogen Breathalyzer in ... Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study). Study Purpose. Small intestinal bacterial overgrowth ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04309396

Study Details | NCT04309396 | Clinical Utility of Handheld ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10132719/

Understanding Our Tests: Hydrogen-Methane Breath ... ... safe for the treatment of small intestine bacterial overgrowth. Aliment Pharmacol Ther 2017;45(5):604–16. [DOI] [PMC free article] [PubMed] [Google Scholar] ...

8. gut.bmj.com gut.bmj.com/content/71/Suppl_1/A8.1

O14 Use of a remote hydrogen breath tester ... In this pilot, the feasibility of patients performing remote SIBO testing using an app-connected personal breath analyzer (AIRE®, FoodMarble) was assessed.

9. foodmarble.com foodmarble.com/gi/science?srsltid=AfmBOorh_XFjcwCNQgtD8yXbYCMo4QJ-LCJt7vYHXrs5lHHUMnRW5Dhz

Science & Validation Breath testing represents an important, simple and safe test to diagnose carbohydrate maldigestion syndromes and small intestinal bacterial overgrowth (SIBO).

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542356513014687

Breath Testing for Small Intestinal Bacterial Overgrowth Hydrogen breath testing provides the simplest noninvasive and widely available diagnostic modality for suspected SIBO.