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

Lactose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754724
• Other study ID #: Pro00107782
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: February 2021
• Source: Vivante Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 1, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lactose Intolerance
• Malabsorption Syndromes

Intervention

Diagnostic Test:
• GIMate
Use of GIMate to detect lactose malabsorption
• H2 Check
Use of H2 Check to detect lactose malabsorption

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Vivante Health	Duke University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Gilat T, Russo S, Gelman-Malachi E, Aldor TA. Lactase in man: a nonadaptable enzyme. Gastroenterology. 1972 Jun;62(6):1125-7. — View Citation

Labayen I, Forga L, González A, Lenoir-Wijnkoop I, Nutr R, Martínez JA. Relationship between lactose digestion, gastrointestinal transit time and symptoms in lactose malabsorbers after dairy consumption. Aliment Pharmacol Ther. 2001 Apr;15(4):543-9. — View Citation

Montalto M, Curigliano V, Santoro L, Vastola M, Cammarota G, Manna R, Gasbarrini A, Gasbarrini G. Management and treatment of lactose malabsorption. World J Gastroenterol. 2006 Jan 14;12(2):187-91. Review. — View Citation

Peuhkuri K, Poussa T, Korpela R. Comparison of a portable breath hydrogen analyser (Micro H2) with a Quintron MicroLyzer in measuring lactose maldigestion, and the evaluation of a Micro H2 for diagnosing hypolactasia. Scand J Clin Lab Invest. 1998 May;58(3):217-24. — View Citation

Rezaie A, Buresi M, Lembo A, Lin H, McCallum R, Rao S, Schmulson M, Valdovinos M, Zakko S, Pimentel M. Hydrogen and Methane-Based Breath Testing in Gastrointestinal Disorders: The North American Consensus. Am J Gastroenterol. 2017 May;112(5):775-784. doi: 10.1038/ajg.2017.46. Epub 2017 Mar 21. — View Citation

Shaw AD, Davies GJ. Lactose intolerance: problems in diagnosis and treatment. J Clin Gastroenterol. 1999 Apr;28(3):208-16. Review. — View Citation

Wang Y, Harvey CB, Hollox EJ, Phillips AD, Poulter M, Clay P, Walker-Smith JA, Swallow DM. The genetically programmed down-regulation of lactase in children. Gastroenterology. 1998 Jun;114(6):1230-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive percent agreement		immediately after the intervention
Primary	Negative percent agreement		immediately after the intervention