Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study) (AIRE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04309396|
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|SIBO Small Bowel Bacterial Overgrowth Syndrome||Device: Hydrogen content recording||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Non-immune Mediated Food Sensitivities (AIRE Study)|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 30, 2022|
|Estimated Study Completion Date :||October 30, 2022|
Experimental: Breath analyzer
Candidates who, after the screening period are eligible to receive the AIRE device.
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.
- Hydrogen content in parts per million (ppm) [ Time Frame: Baseline (1 week) ]Exhaled hydrogen (H2) content as measured over a 1-week period by AIRE on the patient's usual diet at home and the results of the standardized lactulose hydrogen breath test (LHBT) performed in the clinic. Baseline hydrogen content is measured with AIRE device (study intervention) and LHBT (standard of care). Only test with AIRE will be reported.
- Hydrogen content in parts per million (ppm) [ Time Frame: At 2 weeks after antibiotic treatment for positive LHBT ]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.
- Hydrogen content in parts per million (ppm) [ Time Frame: At one month after negative LHBT ]For participants who have a negative LHBT test at baseline, a repeat AIRE test is done at 1 month after baseline test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309396
|Contact: Pankaj J Pasricha, MDfirstname.lastname@example.org|
|Contact: Guillermo Barahona, MDemail@example.com|
|Principal Investigator:||Pankaj Pasricha, MD||Johns Hopkins University|