Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study.

ABSTRACT:

Background

Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosis based on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive laboratory-based equipment and conduction of the testing in a clinical setting.

Objective

The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)-cleared device (H2 Check) for the same indication.

Methods

An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactose malabsorption or a suspected history of lactose intolerance.

Results

A total of 31 p

SUBMITTER: Mathews SC 

PROVIDER: S-EPMC8561400 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature