Evaluation of GIMate Handheld Hydrogen Breath Monitor for Diagnosis of Lactose Malabsorption

Study Overview
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Brief Summary
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The goal of this study is to assess the performance of the Vivante Health GIMate Breathalyzer device in diagnosing lactose malabsorption.

Detailed Description
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Lactose malabsorption is a common condition due to lactase deficiency which results in gastrointestinal symptoms for many which is termed lactose intolerance. Lactase is an enzyme occurring in the intestinal mucosa that hydrolyzes lactose into its constituent parts, galactose and glucose. The enzyme is normally present in neonates, however, for a majority of individuals in the world there is an inherited and irreversible reduction in enzyme activity as individuals age. Secondary lactose malabsorption can also occur when there is injury to the intestinal mucosa from a reversible condition such as infection. The mechanism of hydrogen detection is based on undigested lactose in the colon being fermented by bacteria resulting in the production of hydrogen which is then partially absorbed into the bloodstream and ultimately exhaled by the lungs via the pulmonary circulation and gas exchange. Direct lactase activity can also be measured on tissue obtained through jejunal biopsy via endoscopy. This approach, however, is more invasive, costly, and potentially less reliable given issues relating to sampling bias Current clinical hydrogen breath tests for diagnosis of lactose malabsorption are bulky and expensive for clinical providers to use and obtain. As a result, Vivante Health is testing how effective the GIMate device is in diagnosing lactose malabsorption as an alternative option.

Official Title
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Evaluation of GIMate Handheld Hydrogen Breath Monitor for Diagnosis of Lactose Malabsorption

Conditions
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Lactose Intolerance

Intervention / Treatment
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* Diagnostic Test: GIMate
* Diagnostic Test: H2 Check


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or non-pregnant female between 18 and 55 years of age (inclusive) Able and willing to provide written consent and follow instructions to complete required study procedures (including dietary restriction) and questionnaires. Self-reported or suspected history of lactose malabsorption or lactose intolerance Exclusion Criteria: Exclusion criteria: History of prior gastrointestinal surgery Self-reported history of any chronic gastrointestinal disease (examples include gastroesophageal reflux disease, celiac disease, Crohn's disease, ulcerative colitis, pancreatitis) Self-reported history of endocrine or metabolic disease that may impact gastrointestinal or colonic function (examples include hyper/hypothyroidism, diabetes, etc) Clinically significant cardiovascular, respiratory, renal, hepatic, hematologic, neurologic or psychiatric disease for which chronic therapy (prescription or non- prescription is required) Self-reported history of allergic reaction to any drug or drug component Antibiotic use within 28 days of lactose malabsorption test Use of non-antibiotic prescription or OTC products (dietary or digestive supplements and laxatives) within 14 days of testing. Self-reported use of nicotine-containing products or chronic secondhand smoke exposure within 14 days of testing. Any other condition which in the Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant. Consumption of food after midnight on day of testing (within 12 hours) of testing or consumption of non-water beverage after midnight (or less than 8 hours) prior to testing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIMate<br>Individuals with suspected lactose intolerance who start with GIMate use first | Diagnostic Test: GIMate<br>* Use of GIMate to detect lactose malabsorption<br>Diagnostic Test: H2 Check<br>* Use of H2 Check to detect lactose malabsorption<br>|
| Active Comparator: H2 Check<br>Individuals with suspected lactose intolerance who start with H2 Check use first | Diagnostic Test: GIMate<br>* Use of GIMate to detect lactose malabsorption<br>Diagnostic Test: H2 Check<br>* Use of H2 Check to detect lactose malabsorption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive percent agreement |  | immediately after the intervention | 
| Negative percent agreement |  | immediately after the intervention |