GastroparesisNCT05223881
Gastroparesis in Cystic Fibrosis
A study testing 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT) in people with Gastroparesis, run by University of Miami.
Trial summary
The purpose of this research is to determine if an investigational device called the 13C-Spirulina Gastric Emptying Breath Test (GEBT), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with Cystic Fibrosis (CF). Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2022to 30 Mar 2023
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients age 4 years* and above with a genetically confirmed diagnosis of CF (*This age was chosen as patients younger than 4 years rarely undergo GES)
- Actively being followed at the University of Miami CF Center (i.e. seen within the past 5 years at a University of Miami pediatric or adult pulmonology clinic)
Who cannot join
- History of abdominal surgeries involving gastrointestinal luminal resection (i.e. small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen). Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded.
- Gastrointestinal comorbidities that impact absorption such as Inflammatory Bowel Disease and Celiac Disease
- Known hypersensitivity to Spirulina, egg, milk or wheat allergens
- Patients not able to consume at least 50% of a standard test meal
- Pregnant women
- Adults unable to consent
- Prisoners
About this study
Official title: 13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis
The purpose of this research is to determine if an investigational device called the 13C-Spirulina Gastric Emptying Breath Test (GEBT), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with Cystic Fibrosis (CF).
- Conditions
- Gastroparesis
- Being tested
- 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)
- Keywords
- Cystic Fibrosis, Pediatrics, Altered lung function
- Medical subject headings
- Gastroparesis, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)Device
After an overnight (minimum 8 hours) fast, patients are given a standardized test meal, after which they are administered the GEBT. Patients are asked to hold a glass tube in a comfortable position, take a deep breath and pause momentarily, blow gently into the tube for 5 - 10 seconds, slowly withdraw straw from tube while continuing to breath into tube, and immediately close the tube securely with the cap.
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis | Experimental | Patients who are diagnosed with Cystic Fibrosis. Receives: Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT) |
| Healthy Normal | Active comparator | Patients in this arm will be a sibling of patients who have been diagnosed with Cystic Fibrosis. Receives: Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of gastric emptying
The kPCD value (13CO2 excretion rate) at any time t, is proportional to the rate of gastric emptying. Increasing kPCD values represent increasing rates of gastric emptying.
Measured: 4 hours
Secondary outcomes (1)
Rate of gastric emptying over time
The kPCD value (13CO2 excretion rate) at any time t, is proportional to the rate of gastric emptying. Increasing kPCD values represent increasing rates of gastric emptying.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start14 Feb 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Why it stopped: Study is not feasible at this time due to staffing limitations
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphna Katz, University of Miami
- Investigators
- Daphna Katz, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223881
- Sponsor's protocol ID
- 20211043
- Status last verified
- Apr 2022
- First submitted
- 24 Jan 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05223881
- Acronym / sponsor ID
- 20211043
- Conditions
- Gastroparesis
- Keywords
- Cystic Fibrosis, Pediatrics, Altered lung function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is not feasible at this time due to staffing limitations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 14 Feb 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 4 Feb 2022 (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 research is to determine if an investigational device called the 13C-Spirulina Gastric Emptying Breath Test (GEBT), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with Cystic Fibrosis (CF).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis | Experimental | Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)Patients who are diagnosed with Cystic Fibrosis. |
| Healthy Normal | Active comparator | Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)Patients in this arm will be a sibling of patients who have been diagnosed with Cystic Fibrosis. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 4 years* and above with a genetically confirmed diagnosis of CF (*This age was chosen as patients younger than 4 years rarely undergo GES)
- Actively being followed at the University of Miami CF Center (i.e. seen within the past 5 years at a University of Miami pediatric or adult pulmonology clinic)
Key exclusion criteria (7 listed)
- History of abdominal surgeries involving gastrointestinal luminal resection (i.e. small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen). Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded.
- Gastrointestinal comorbidities that impact absorption such as Inflammatory Bowel Disease and Celiac Disease
- Known hypersensitivity to Spirulina, egg, milk or wheat allergens
- Patients not able to consume at least 50% of a standard test meal
- Pregnant women
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 |
|---|---|---|
| 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)After an overnight (minimum 8 hours) fast, patients are given a standardized test meal, after which they are administered the GEBT. Patients are asked to hold a glass tube in a comfortable position, take a deep breath and pause momentarily, blow gently into the tube for 5 - 10 seconds, slowly withdraw straw from tube while continuing to breath into tube, and immediately close the tube securely with the cap. | Device | Cystic Fibrosis, Healthy Normal |
Primary outcome
Rate of gastric emptying
Time frame: 4 hours
The kPCD value (13CO2 excretion rate) at any time t, is proportional to the rate of gastric emptying. Increasing kPCD values represent increasing rates of gastric emptying.
1 secondary outcome
Rate of gastric emptying over time
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- 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.
Daphna Katz, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A study testing 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT) in people with Gastroparesis, run by University of Miami.
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 7 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: withdrawn, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of gastric emptying (time frame: 4 hours). 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 2 May 2022.