GastroparesisNCT04772261
GEBT Lot-to-Lot and Biological Variability
A study testing 13C-Spirulina GEBT in people with Gastroparesis, run by Cairn Diagnostics at 1 site in United States.
Trial summary
The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- 13C-Spirulina GEBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to 10 Jan 2022
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, 18-85 years old at time of signing the informed consent form
- Ability to eat test meal and provide breath samples
Who cannot join
- History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption.
- History of abdominal surgery except appendectomy
- Use of any medications that may alter gastric motility within two days of the study
- Use of narcotics or anticholinergics within two days of the study
- Females on hormone replacement therapy other than birth control medications
- Pregnancy
- Intolerance or allergy to any component of GEBT test meal
- History of neurologic or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study
The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.
Read the detailed description
In this study participants will participate in one or two arms of the study. In one arm the participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix drug lots. In the second arm, the participants will be administered GEBT tests from the same 13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the FDA-approved labeling.
- Conditions
- Gastroparesis
- Being tested
- 13C-Spirulina GEBT
- Keywords
- Gastroenterology, Gastric emptying breath test
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-Spirulina GEBTDiagnostic test
Various lots of 13C-Spirulina GEBT test meals
| Study group | Role | What they receive |
|---|---|---|
| Lot-to-Lot Variability | Experimental | Participants will be administered up to six different 13C-Spirulina test meal lots Receives: Diagnostic Test: 13C-Spirulina GEBT |
| Biological Variability | Experimental | Participants will be administered the same 13C-Spirulina test meal lot on two different occasions Receives: Diagnostic Test: 13C-Spirulina GEBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lot to Lot Variability
Participant kPCD values at each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be plotted to compare in vivo results across each lot of material
Measured: up to 3 months
Lot to Lot Variability
Pooled kPCD and standard deviations for each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be calculated and compared for the lot-to-lot comparisons
Measured: up to 3 months
Lot to Lot Variability
Each set of pooled 13C-Spirulina test meal lot kPCD values will be calculated using a t-test or ANOVA to determine statistical equivalence
Measured: up to 3 months
Biological Variability
Participant kPCD values at each measured timepoint from the same 13C-Spirulina GEBT test meal will be plotted to compare against each other
Measured: Up to 3 months
Biological Variability
Pooled, within subject standard deviations of duplicate measurements of kPCD values at each measured timepoint from the same lot of 13C-Spirulina GEBT test meal will be calculated for biological variation using Bartlett's test for homogeneity of variances
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start5 Feb 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairn Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Ryder, MD, PhD, Principal investigator, Cairn Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772261
- Sponsor's protocol ID
- PRO-CD-050
- Status last verified
- Jan 2022
- First submitted
- 23 Feb 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study
- ClinicalTrials.gov ID
- NCT04772261
- Acronym / sponsor ID
- PRO-CD-050
- Conditions
- Gastroparesis
- Keywords
- Gastroenterology, Gastric emptying breath test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cairn DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 26 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 purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.
Detailed description
In this study participants will participate in one or two arms of the study. In one arm the participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix drug lots. In the second arm, the participants will be administered GEBT tests from the same 13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the FDA-approved labeling.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lot-to-Lot Variability | Experimental | Diagnostic Test: 13C-Spirulina GEBTParticipants will be administered up to six different 13C-Spirulina test meal lots |
| Biological Variability | Experimental | Diagnostic Test: 13C-Spirulina GEBTParticipants will be administered the same 13C-Spirulina test meal lot on two different occasions |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females, 18-85 years old at time of signing the informed consent form
- Ability to eat test meal and provide breath samples
Key exclusion criteria (8 listed)
- History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption.
- History of abdominal surgery except appendectomy
- Use of any medications that may alter gastric motility within two days of the study
- Use of narcotics or anticholinergics within two days of the study
- Females on hormone replacement therapy other than birth control medications
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 |
|---|---|---|
| 13C-Spirulina GEBTVarious lots of 13C-Spirulina GEBT test meals | Diagnostic test | Biological Variability, Lot-to-Lot Variability |
Primary outcome
Lot to Lot Variability
Time frame: up to 3 months
Participant kPCD values at each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be plotted to compare in vivo results across each lot of material
Lot to Lot Variability
Time frame: up to 3 months
Pooled kPCD and standard deviations for each measured timepoint from each lot of 13C-Spirulina GEBT test meal will be calculated and compared for the lot-to-lot comparisons
Lot to Lot Variability
Time frame: up to 3 months
Each set of pooled 13C-Spirulina test meal lot kPCD values will be calculated using a t-test or ANOVA to determine statistical equivalence
Biological Variability
Time frame: Up to 3 months
Participant kPCD values at each measured timepoint from the same 13C-Spirulina GEBT test meal will be plotted to compare against each other
Biological Variability
Time frame: Up to 3 months
Pooled, within subject standard deviations of duplicate measurements of kPCD values at each measured timepoint from the same lot of 13C-Spirulina GEBT test meal will be calculated for biological variation using Bartlett's test for homogeneity of variances
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 18 Jan 2022.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Alex Ryder, MD, PhD principal investigator
Cairn Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 13C-Spirulina GEBT in people with Gastroparesis, run by Cairn Diagnostics 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 2 inclusion and 8 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 18 Jan 2022. 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?
Lot to Lot Variability (time frame: up to 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2022.