Status:
COMPLETED
Evaluation of GIMate Handheld Hydrogen Breath Monitor for Diagnosis of Lactose Malabsorption
Lead Sponsor:
Vivante Health
Collaborating Sponsors:
Duke University
Conditions:
Lactose Intolerance
Eligibility:
All Genders
18-55 years
Phase:
NA
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 int...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Exclusion criteria:
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04754724
Start Date
April 1 2021
End Date
August 1 2021
Last Update
September 28 2021
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27517