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

NCT04754724 | Completed

• 1 other identifier: Pro00107782
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (2)

• Positive percent agreement

  immediately after the intervention

• Negative percent agreement

  immediately after the intervention

Study Arms (2)

GIMate

EXPERIMENTAL

Individuals with suspected lactose intolerance who start with GIMate use first

Diagnostic Test: GIMate; Diagnostic Test: H2 Check

H2 Check

ACTIVE COMPARATOR

Individuals with suspected lactose intolerance who start with H2 Check use first

Diagnostic Test: GIMate; Diagnostic Test: H2 Check

Interventions

GIMate DIAGNOSTIC_TEST

Use of GIMate to detect lactose malabsorption

GIMate; H2 Check

H2 Check DIAGNOSTIC_TEST

Use of H2 Check to detect lactose malabsorption

GIMate; H2 Check

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivante Health: lead
• Duke University: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27517, United States

Location

Related Publications (8)

• 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. doi: 10.3748/wjg.v12.i2.187.

  PMID: 16482616 BACKGROUND

• Gilat T, Russo S, Gelman-Malachi E, Aldor TA. Lactase in man: a nonadaptable enzyme. Gastroenterology. 1972 Jun;62(6):1125-7. No abstract available.

  PMID: 5068338 BACKGROUND

• 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. doi: 10.1016/s0016-5085(98)70429-9.

  PMID: 9609760 BACKGROUND

• Labayen I, Forga L, Gonzalez A, Lenoir-Wijnkoop I, Nutr R, Martinez 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. doi: 10.1046/j.1365-2036.2001.00952.x.

  PMID: 11284784 BACKGROUND

• Shaw AD, Davies GJ. Lactose intolerance: problems in diagnosis and treatment. J Clin Gastroenterol. 1999 Apr;28(3):208-16. doi: 10.1097/00004836-199904000-00005.

  PMID: 10192605 BACKGROUND

• 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.

  PMID: 28323273 BACKGROUND

• 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. doi: 10.1080/00365519850186607.

  PMID: 9670345 BACKGROUND

• Mathews SC, Templeton S, Taylor SK, Harris S, Stewart M, Raja SM. Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study. JMIR Form Res. 2021 Oct 18;5(10):e33009. doi: 10.2196/33009.

  PMID: 34544034 DERIVED

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: April 1, 2021
• Primary Completion: July 15, 2021
• Study Completion: August 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)