GastroparesisNCT05055336
Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia
A study testing Gastric emptying breath test and Stomach ultrasound in people with Gastroparesis and Dyspepsia, run by University of Miami.
Trial summary
The purpose of this research is to further study the relationship between gastroparesis (GP) (a condition in which the stomach cannot empty itself of food in a normal fashion) and functional dyspepsia (FD) (frequent symptoms of indigestion that have no obvious cause). Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis, Dyspepsia
- What is being tested?
- Gastric emptying breath test and Stomach ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Apr 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Able to complete the Pediatric Cardinal Symptoms Questionnaire
- Both parent and child must be able to speak and understand English or Spanish
Who cannot join
- Have global developmental delay, autism disorder, or psychosis
- Are nonverbal and/or illiterate
- Lack fluency in English or Spanish
- Have other GI comorbidities such as inflammatory bowel disease, celiac disease, eosinophilic esophagitis, peptic ulcer disease, GI malignancy, or gastroesophageal reflux disease responsive to medications (medical records will be reviewed to detect these exclusions)
- Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure.
- Healthy child presenting to their well child care visit must not report a history of dyspepsia, have a history of any gastrointestinal disease, or be taking any medication that can disturb the GI tract motility.
About this study
Official title: Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia: Toward Individualized Care in Functional Abdominal Pain Disorders
The purpose of this research is to further study the relationship between gastroparesis (GP) (a condition in which the stomach cannot empty itself of food in a normal fashion) and functional dyspepsia (FD) (frequent symptoms of indigestion that have no obvious cause).
- Conditions
- Gastroparesis, Dyspepsia
- Being tested
- Gastric emptying breath test, Stomach ultrasound
- Medical subject headings
- Gastroparesis, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric emptying breath testOther
The gastric emptying breath test is used to diagnose gastroparesis. Participants ingest spirulina in a meal and samples are taken every 45 minutes for 4 hours.
Stomach ultrasoundOther
Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis | Experimental | Participants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once. Receives: Other: Gastric emptying breath test; Other: Stomach ultrasound |
| Dyspepsia | Experimental | Participants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once. Receives: Other: Gastric emptying breath test; Other: Stomach ultrasound |
| Healthy Controls | Experimental | Participants in this group are children that do not have gastroparesis, functional dyspepsia, or any other gastroenterology condition. Participants will be getting an ultrasound once. Receives: Other: Stomach ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying rate
As measured by the spirulina breath test
Measured: up to 6 months
Secondary outcomes (2)
Percentage of food retained in the stomach
Fundic accommodation will be reported as the percentage of food retained in the fundus using an ultrasound before and after meal ingestion.
Measured: Day 1
Pediatric Cardinal Symptoms Questionnaire Scores
The pediatric symptoms questionnaires has a total score ranging from 0-600. Higher score means worse symptoms.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 May 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Why it stopped: Principal Investigator left the institution.
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
- Collaborators
- American Neurogastroenterology and Motility Society
- Responsible party
- Sponsor
- Investigators
- Liz Febo-Rodriguez, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055336
- Sponsor's protocol ID
- 20210662
- Status last verified
- Oct 2022
- First submitted
- 23 Aug 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia: Toward Individualized Care in Functional Abdominal Pain Disorders
- ClinicalTrials.gov ID
- NCT05055336
- Acronym / sponsor ID
- 20210662
- Conditions
- Gastroparesis, Dyspepsia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Neurogastroenterology and Motility Society
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 24 Sep 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 research is to further study the relationship between gastroparesis (GP) (a condition in which the stomach cannot empty itself of food in a normal fashion) and functional dyspepsia (FD) (frequent symptoms of indigestion that have no obvious cause).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis | Experimental | Other: Gastric emptying breath test, Other: Stomach ultrasoundParticipants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once. |
| Dyspepsia | Experimental | Other: Gastric emptying breath test, Other: Stomach ultrasoundParticipants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once. |
| Healthy Controls | Experimental | Other: Stomach ultrasoundParticipants in this group are children that do not have gastroparesis, functional dyspepsia, or any other gastroenterology condition. Participants will be getting an ultrasound once. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Able to complete the Pediatric Cardinal Symptoms Questionnaire
- Both parent and child must be able to speak and understand English or Spanish
Key exclusion criteria (6 listed)
- Have global developmental delay, autism disorder, or psychosis
- Are nonverbal and/or illiterate
- Lack fluency in English or Spanish
- Have other GI comorbidities such as inflammatory bowel disease, celiac disease, eosinophilic esophagitis, peptic ulcer disease, GI malignancy, or gastroesophageal reflux disease responsive to medications (medical records will be reviewed to detect these exclusions)
- Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure.
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 |
|---|---|---|
| Gastric emptying breath testThe gastric emptying breath test is used to diagnose gastroparesis. Participants ingest spirulina in a meal and samples are taken every 45 minutes for 4 hours. | Other | Dyspepsia, Gastroparesis |
| Stomach ultrasoundUltrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes. | Other | Dyspepsia, Gastroparesis, Healthy Controls |
Primary outcome
Gastric emptying rate
Time frame: up to 6 months
As measured by the spirulina breath test
2 secondary outcomes
Percentage of food retained in the stomach
Time frame: Day 1
Pediatric Cardinal Symptoms Questionnaire Scores
Time frame: Up to 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 10 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Gastroparesis
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
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.
Liz Febo-Rodriguez, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A study testing Gastric emptying breath test and Stomach ultrasound in people with Gastroparesis and Dyspepsia, 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 6 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 10 Oct 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?
Gastric emptying rate (time frame: up to 6 months). 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 10 Oct 2022.