Cyclic Vomiting SyndromeNCT03470181
Applying Nutrient Drink Test in Understanding Pathophysiology of CVS
An observational study of Cyclic Vomiting Syndrome, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Cyclic vomiting syndrome is a disorder characterized by nausea and vomiting, separated by periods without any symptoms. There is very little research on this field at this point and most doctors do not fully understand the disorder. The goal of this study is to assess how the stomach empties food. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cyclic Vomiting Syndrome
- What is being tested?
- Ensure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 29 May 2018
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study seeks to enroll adult patients diagnosed with Cyclic Vomiting Syndrome, as well as healthy controls
Who may be able to join
- Diagnosed with Cyclic Vomiting (or Healthy Volunteer)
- Age 18 or greater
Who cannot join
- Age Under 18
- History of gastric surgery
- History of marijuana use
- History of Gastroparesis
- History of Diabetes mellitus II
- Upper endoscopy with known obstructive gastric disease
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- Current pregnancy or lactation
- Active inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
- Severe renal disease (GFR <15/dialysis dependent)
- Active malignancy (diagnosed in last 5 years)
- Allergy/intolerance to liquid Ensure®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applying Nutrient Drink Test in Understanding Pathophysiology of Cyclic Vomiting Syndrome
Cyclic vomiting syndrome is a disorder characterized by nausea and vomiting, separated by periods without any symptoms. There is very little research on this field at this point and most doctors do not fully understand the disorder. The goal of this study is to assess how the stomach empties food. Participants will be asked to participate in this study because either (a) they have been diagnosed and/or treated for cyclic vomiting syndrome in the past, or (b) they are physically healthy. The study seeks to compare how a healthy person's stomach empties to how the stomach of someone with cyclic vomiting disorder empties.
Read the detailed description
Up to 14% of unexplained vomiting in adults is attributed to an under recognized and often misdiagnosed disorder termed cyclic vomiting syndrome (CVS). As CVS is better understood, gastroenterologists are increasingly recognizing the importance of timely diagnosis and early management for this chronic and debilitating disorder. Currently, the only gold standard diagnostic strategy involves evaluating clinical criteria set by the Rome Foundation, such as vomiting frequency and duration of episodes. Outside of these subjective criteria, no definitive and objective diagnostic strategy for cyclic vomiting syndrome exists.
Developing diagnostic strategies has been difficult given the exact etiology of CVS is still unknown. One physiologic theory includes rapid gastric emptying (GE)-or a dumping-like syndrome related to impaired gastric accommodation. A retrospective analysis observed rapid gastric emptying by standard 4-hour scintigraphic gastric emptying study in 80% of subjects, suggesting a relationship with CVS and rapid GE. In turn, rapid emptying has been hypothesized to relate with abnormal gastric accommodation - the reflex allowing storage of food through increased fundic volume. This physiologic abnormality can be readily and easily measured using non-invasive tools, but have never been tested in CVS. To explore this further, we aim to determine if CVS patients have abnormal gastric accommodation measured by nutrient drink test.
- Conditions
- Cyclic Vomiting Syndrome
- Being tested
- Ensure
- Keywords
- Chronic nausea, intermittent vomiting, impaired accommodation
- Medical subject headings
- Familial cyclic vomiting syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsureDietary supplement
Participants will perform a Nutrient Drink Test. This consists of drinking 125mL of liquid Ensure four times, at five-minute intervals.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Diagnosed CVS | This cohort will consist of 15 current patients previously diagnosed with Cyclic Vomiting Syndrome. Receives: Dietary Supplement: Ensure | |
| Healthy Volunteers | This cohort will consist of 15 healthy volunteers, with no history of Cyclic Vomiting. Receives: Dietary Supplement: Ensure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated volume
The amount of nutrient drink consumed before the participant reports feelings of unbearable fullness.
Measured: Within 30 minutes of beginning the test.
Secondary outcomes (1)
Total Aggregate Symptom Score
Participant-Reported impressions of fullness, bloating, or abdominal pain, measures on 100mm visual analog scale
Measured: Within 30 minutes of the beginning of the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Feb 2018
- Primary completion29 May 2018
- Study completion29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclic Vomiting SyndromeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Gabbard, MD, The Cleveland Clinic
- Investigators
- Scott Gabbard, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470181
- Sponsor's protocol ID
- 17-1138
- Status last verified
- Feb 2020
- First submitted
- 13 Mar 2018
- Last updated
- 27 Feb 2020
- 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 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Nutrient Drink Test in Understanding Pathophysiology of Cyclic Vomiting Syndrome
- ClinicalTrials.gov ID
- NCT03470181
- Acronym / sponsor ID
- 17-1138
- Conditions
- Cyclic Vomiting Syndrome
- Keywords
- Chronic nausea, intermittent vomiting, impaired accommodation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 19 Mar 2018 (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.
Cyclic vomiting syndrome is a disorder characterized by nausea and vomiting, separated by periods without any symptoms. There is very little research on this field at this point and most doctors do not fully understand the disorder. The goal of this study is to assess how the stomach empties food. Participants will be asked to participate in this study because either (a) they have been diagnosed and/or treated for cyclic vomiting syndrome in the past, or (b) they are physically healthy. The study seeks to compare how a healthy person's stomach empties to how the stomach of someone with cyclic vomiting disorder empties.
Detailed description
Up to 14% of unexplained vomiting in adults is attributed to an under recognized and often misdiagnosed disorder termed cyclic vomiting syndrome (CVS). As CVS is better understood, gastroenterologists are increasingly recognizing the importance of timely diagnosis and early management for this chronic and debilitating disorder. Currently, the only gold standard diagnostic strategy involves evaluating clinical criteria set by the Rome Foundation, such as vomiting frequency and duration of episodes. Outside of these subjective criteria, no definitive and objective diagnostic strategy for cyclic vomiting syndrome exists.
Developing diagnostic strategies has been difficult given the exact etiology of CVS is still unknown. One physiologic theory includes rapid gastric emptying (GE)-or a dumping-like syndrome related to impaired gastric accommodation. A retrospective analysis observed rapid gastric emptying by standard 4-hour scintigraphic gastric emptying study in 80% of subjects, suggesting a relationship with CVS and rapid GE. In turn, rapid emptying has been hypothesized to relate with abnormal gastric accommodation - the reflex allowing storage of food through increased fundic volume. This physiologic abnormality can be readily and easily measured using non-invasive tools, but have never been tested in CVS. To explore this further, we aim to determine if CVS patients have abnormal gastric accommodation measured by nutrient drink test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Diagnosed CVS | – | Dietary Supplement: EnsureThis cohort will consist of 15 current patients previously diagnosed with Cyclic Vomiting Syndrome. |
| Healthy Volunteers | – | Dietary Supplement: EnsureThis cohort will consist of 15 healthy volunteers, with no history of Cyclic Vomiting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study seeks to enroll adult patients diagnosed with Cyclic Vomiting Syndrome, as well as healthy controls
Key inclusion criteria (2 listed)
- Diagnosed with Cyclic Vomiting (or Healthy Volunteer)
- Age 18 or greater
Key exclusion criteria (11 listed)
- Age Under 18
- History of gastric surgery
- History of marijuana use
- History of Gastroparesis
- History of Diabetes mellitus II
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 |
|---|---|---|
| EnsureParticipants will perform a Nutrient Drink Test. This consists of drinking 125mL of liquid Ensure four times, at five-minute intervals. | Dietary supplement | Healthy Volunteers, Participants with Diagnosed CVS |
Primary outcome
Maximum tolerated volume
Time frame: Within 30 minutes of beginning the test.
The amount of nutrient drink consumed before the participant reports feelings of unbearable fullness.
1 secondary outcome
Total Aggregate Symptom Score
Time frame: Within 30 minutes of the beginning of the test
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 27 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Cyclic Vomiting Syndrome
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A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
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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.
Scott Gabbard, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cyclic Vomiting Syndrome, run by The Cleveland Clinic 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 11 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 27 Feb 2020. 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?
Maximum tolerated volume (time frame: Within 30 minutes of beginning the test.). 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 27 Feb 2020.