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

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

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.

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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

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.




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.



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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

Information from the National Library of Medicine

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


Contacts
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Contact: Pankaj J Pasricha, MD 4105501793 pasricha@jhu.edu
Contact: Guillermo Barahona, MD 4105508871 gbaraho1@jhmi.edu

Locations
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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
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Principal Investigator: Pankaj Pasricha, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04309396    
Other Study ID Numbers: IRB00204104
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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