NCT04754724

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Vivante Health · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lactose Intolerance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	GIMate	Use of GIMate to detect lactose malabsorption
DIAGNOSTIC_TEST	H2 Check	Use of H2 Check to detect lactose malabsorption

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-07-15
• Completion: 2021-08-01
• First posted: 2021-02-15
• Last updated: 2021-09-28

Locations

1 site across 1 country: United States