Hydrogen Breathalyzer for Small Intestinal Bacterial Overgrowth
(AIRE Trial)

Dr. Glenn J. Treisman, MD | Baltimore ...

Overseen ByGuillermo Barahona, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Antibiotics, Inflammatory bowel disease, others

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

Trial Summary

What is the purpose of this trial?

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 because current tests are not very accurate and are inconvenient. The device works by detecting hydrogen gas produced by bacteria in the small intestine and provides immediate results through a smartphone app.

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 data supports the effectiveness of the treatment AIRE for small intestinal bacterial overgrowth?

The hydrogen breath test is a common method to diagnose small intestinal bacterial overgrowth (SIBO) by measuring hydrogen levels in the breath, which can indicate bacterial overgrowth. While the effectiveness of the AIRE treatment specifically is not directly addressed, hydrogen breath tests are widely used to identify SIBO, and treatments often include antibiotics that reduce symptoms.¹ ² ³ ⁴ ⁵

How is the AIRE treatment for small intestinal bacterial overgrowth different from other treatments?

The AIRE treatment is unique because it uses a hydrogen breathalyzer to detect small intestinal bacterial overgrowth, which is a non-invasive and easy-to-perform method compared to traditional treatments that often involve antibiotics. This approach focuses on identifying the condition through breath analysis rather than directly treating it with medication.¹ ⁴ ⁶ ⁷ ⁸

Research Team

Glenn Treisman, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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 am 18 years old or older.

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

See 3 more

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.

See 1 more

Timeline

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

Treatment Details

Interventions

AIRE

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Breath analyzerExperimental Treatment1 Intervention

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