N/A
N=43
Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study)
SIBO · Small Bowel Bacterial Overgrowth Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04309396 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Hydrogen Content in Parts Per Million (Ppm) — 3.5 ppm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrogen content recording (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hydrogen Content in Parts Per Million (Ppm) |
8.5 | — |
| PRIMARY Hydrogen Content in Parts Per Million (Ppm) |
8.5 | — |
| PRIMARY Hydrogen Content in Parts Per Million (Ppm) |
8.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04309396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.