NCT04309396

Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study)

Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Non-immune Mediated Food Sensitivities (AIRE Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• SIBO
• Small Bowel Bacterial Overgrowth Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-03-10
• Completion: 2025-03-20
• First posted: 2020-03-16
• Last updated: 2025-05-28
• Results posted: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study