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

NCT04309396 | Completed Results FDA Device

• 1 other identifier: IRB00204104
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SIBO; Small Bowel Bacterial Overgrowth Syndrome

Keywords

SIBO

Outcome Measures

Primary Outcomes (3)

• Hydrogen Content in Parts Per Million (Ppm)

  Exhaled hydrogen (H2) content as measured over a 1-week period by AIRE on the patient's usual diet at home. Mean of one week readings is reported.

  Up to 1 week

• Hydrogen Content in Parts Per Million (Ppm)

  For participants who have a positive LHBT test at baseline, antibiotics are prescribed as part of standard of care. These participants will have a repeat AIRE test at 2 weeks post antibiotic treatment.

  2 weeks after antibiotic treatment for positive LHBT

• Hydrogen Content in Parts Per Million (Ppm)

  For participants who have a negative LHBT test at baseline, a repeat AIRE test is done at 1 month after baseline test.

  One month after negative LHBT

Study Arms (1)

Breath analyzer

EXPERIMENTAL

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

Device: Hydrogen content recording

Interventions

Hydrogen content recording DEVICE

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.

Breath analyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• FoodMarble: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Results Point of Contact

• Title: Dr. Jay Pasricha
• Organization: Mayo Clinic Arizona

pasricha.jay@mayo.edu

(480)301-4279

Study Officials

• Glenn Treisman, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: October 1, 2020
• Primary Completion: March 10, 2025
• Study Completion: March 20, 2025
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)