Status:
COMPLETED
Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study)
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
FoodMarble
Conditions:
SIBO
Small Bowel Bacterial Overgrowth Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 fermenta...
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 fermenta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04309396
Start Date
October 1 2020
End Date
March 20 2025
Last Update
May 28 2025
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224