Lactose IntoleranceNCT04754724
Evaluation of GIMate Handheld Hydrogen Breath Monitor for Diagnosis of Lactose Malabsorption
A study testing GIMate and H2 Check in people with Lactose Intolerance, run by Vivante Health at 1 site in United States.
Trial summary
The goal of this study is to assess the performance of the Vivante Health GIMate Breathalyzer device in diagnosing lactose malabsorption. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- GIMate and H2 Check
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to assess the performance of the Vivante Health GIMate Breathalyzer device in diagnosing lactose malabsorption.
Read the 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
- Being tested
- GIMate, H2 Check
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIMateDiagnostic test
Use of GIMate to detect lactose malabsorption
H2 CheckDiagnostic test
Use of H2 Check to detect lactose malabsorption
| Study group | Role | What they receive |
|---|---|---|
| GIMate | Experimental | Individuals with suspected lactose intolerance who start with GIMate use first Receives: Diagnostic Test: GIMate; Diagnostic Test: H2 Check |
| H2 Check | Active comparator | Individuals with suspected lactose intolerance who start with H2 Check use first Receives: Diagnostic Test: GIMate; Diagnostic Test: H2 Check |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive percent agreement
Measured: immediately after the intervention
Negative percent agreement
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Apr 2021
- Primary completion15 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivante Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754724
- Sponsor's protocol ID
- Pro00107782
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16482616Gilat T, Russo S, Gelman-Malachi E, Aldor TA. Lactase in man: a nonadaptable enzyme. Gastroenterology. 1972 Jun;62(6):1125-7. No abstract available.
PubMed 5068338Wang 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.
PubMed 9609760Labayen 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.
PubMed 11284784Shaw 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.
PubMed 10192605Rezaie 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.
PubMed 28323273Peuhkuri 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.
PubMed 9670345Mathews 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.
PubMed 34544034
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GIMate Handheld Hydrogen Breath Monitor for Diagnosis of Lactose Malabsorption
- ClinicalTrials.gov ID
- NCT04754724
- Acronym / sponsor ID
- Pro00107782
- Conditions
- Lactose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vivante HealthIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIMate | Experimental | Diagnostic Test: GIMate, Diagnostic Test: H2 CheckIndividuals with suspected lactose intolerance who start with GIMate use first |
| H2 Check | Active comparator | Diagnostic Test: GIMate, Diagnostic Test: H2 CheckIndividuals with suspected lactose intolerance who start with H2 Check use first |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIMateUse of GIMate to detect lactose malabsorption | Diagnostic test | GIMate, H2 Check |
| H2 CheckUse of H2 Check to detect lactose malabsorption | Diagnostic test | GIMate, H2 Check |
Primary outcome
Positive percent agreement
Time frame: immediately after the intervention
Negative percent agreement
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 16482616Montalto 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.
- Background: PubMed 5068338Gilat T, Russo S, Gelman-Malachi E, Aldor TA. Lactase in man: a nonadaptable enzyme. Gastroenterology. 1972 Jun;62(6):1125-7. No abstract available.
- Background: PubMed 9609760Wang 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.
- Background: PubMed 11284784Labayen 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.
- Background: PubMed 10192605Shaw 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.
- Background: PubMed 28323273Rezaie 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.
- Background: PubMed 9670345Peuhkuri 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.
- Derived from this study: PubMed 34544034Mathews 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIMate and H2 Check in people with Lactose Intolerance, run by Vivante Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive percent agreement (time frame: immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754724, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.