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

• ClinicalTrials.gov Identifier: NCT04309396
• Recruitment Status: Recruiting
• First Posted: March 16, 2020
• Last Update Posted: October 14, 2020
• Sponsor: Johns Hopkins University
• Collaborator: FoodMarble
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
SIBO; Small Bowel Bacterial Overgrowth Syndrome	Device: Hydrogen content recording	Not Applicable

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 fermentation of carbohydrates before reaching the colon. Commonly recognized causes include gastric achlorhydria (i.e. due to longstanding proton pump inhibitor (PPI) use), post-surgical bowel stasis, and gastrointestinal motility disorders leading to bowel stasis. Although SIBO is commonly suspected, a major limitation in the field is the lack of a highly accurate test for SIBO. The current gold standard relies on the demonstration of an early rise in breath hydrogen concentration in response to an orally ingested carbohydrate (commonly, lactulose) but its accuracy is about 50%. This may be because it is a one-time snapshot with an artificial substrate. Further, it has to be performed in a clinic, takes up to 5 hours and is relatively expensive. The purpose of this study is to evaluate the clinical utility of a portable medical device called AIRE, which is a validated and commercially available handheld breathalyzer that measures hydrogen content in the breath and connects via Bluetooth to an associated smartphone application to provide immediate results and visual feedback after use. H2 concentrations determined by the AIRE device showed significant correlation with those measured by LHBT. The AIRE device therefore provides an alternative way to measure exhaled H2 that has the potential for addressing many of the limitations of the standard breath test.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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

Arms and Interventions

Arm

Intervention/treatment

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Pankaj J Pasricha, MD; 4105501793; pasricha@jhu.edu

Contact: Guillermo Barahona, MD; 4105508871; gbaraho1@jhmi.edu

Locations

United States, Maryland

Johns Hopkins Bayview Medical Center; Recruiting

Baltimore, Maryland, United States, 21224

Contact: Pankaj J Pasricha, MD 410-550-1793 pasricha@jhu.edu

Contact: Guillermo A Barahona, MD 410-550-8871 gbaraho1@jhmi.edu

Sponsors and Collaborators

Johns Hopkins University

FoodMarble

Investigators

• Principal Investigator: Pankaj Pasricha, MD; Johns Hopkins University

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04309396
• Other Study ID Numbers: IRB00204104
• First Posted: March 16, 2020
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Johns Hopkins University:

SIBO

Additional relevant MeSH terms:

Blind Loop Syndrome; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases