Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE … (NCT04309396) | Clinical Trial Compass
CompletedNot Applicable
Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study)
United States45 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hydrogen Content in Parts Per Million (Ppm)
Timeframe: Up to 1 week
2
Hydrogen Content in Parts Per Million (Ppm)
Timeframe: 2 weeks after antibiotic treatment for positive LHBT