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

Not Applicable

Completed

• Conditions: Lactose Intolerance
• Interventions: Diagnostic Test: GIMate; Diagnostic Test: H2 Check

• Registration Number: NCT04754724
• Lead Sponsor: Vivante Health

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-15
• Study Start: 2021-04-01
• Primary Completion: 2021-07-15
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Healthy male or non-pregnant female between 18 and 55 years of age (inclusive)
2. Able and willing to provide written consent and follow instructions to complete required study procedures (including dietary restriction) and questionnaires.
3. Self-reported or suspected history of lactose malabsorption or lactose intolerance

Exclusion Criteria

Exclusion criteria:

1. History of prior gastrointestinal surgery
2. Self-reported history of any chronic gastrointestinal disease (examples include gastroesophageal reflux disease, celiac disease, Crohn's disease, ulcerative colitis, pancreatitis)
3. Self-reported history of endocrine or metabolic disease that may impact gastrointestinal or colonic function (examples include hyper/hypothyroidism, diabetes, etc)
4. Clinically significant cardiovascular, respiratory, renal, hepatic, hematologic, neurologic or psychiatric disease for which chronic therapy (prescription or non- prescription is required)
5. Self-reported history of allergic reaction to any drug or drug component
6. Antibiotic use within 28 days of lactose malabsorption test
7. Use of non-antibiotic prescription or OTC products (dietary or digestive supplements and laxatives) within 14 days of testing.
8. Self-reported use of nicotine-containing products or chronic secondhand smoke exposure within 14 days of testing.
9. 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.
10. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GIMate	GIMate	Individuals with suspected lactose intolerance who start with GIMate use first
H2 Check	H2 Check	Individuals with suspected lactose intolerance who start with H2 Check use first
H2 Check	GIMate	Individuals with suspected lactose intolerance who start with H2 Check use first
GIMate	H2 Check	Individuals with suspected lactose intolerance who start with GIMate use first

Primary Outcome Measures

Name	Time	Method
Negative percent agreement	immediately after the intervention
Positive percent agreement	immediately after the intervention

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States