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Applying Nutrient Drink Test in Understanding Pathophysiology of CVS

Applying Nutrient Drink Test in Understanding Pathophysiology of Cyclic Vomiting Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03470181
Enrollment
24
Registered
2018-03-19
Start date
2018-02-01
Completion date
2018-05-29
Last updated
2020-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cyclic Vomiting Syndrome

Keywords

Chronic nausea, intermittent vomiting, impaired accommodation

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTEnsure

Participants will perform a Nutrient Drink Test. This consists of drinking 125mL of liquid Ensure four times, at five-minute intervals.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Diagnosed with Cyclic Vomiting (or Healthy Volunteer) * Age 18 or greater

Exclusion criteria

* 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 * 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®

Design outcomes

Primary

MeasureTime frameDescription
Maximum tolerated volumeWithin 30 minutes of beginning the test.The amount of nutrient drink consumed before the participant reports feelings of unbearable fullness.

Secondary

MeasureTime frameDescription
Total Aggregate Symptom ScoreWithin 30 minutes of the beginning of the testParticipant-Reported impressions of fullness, bloating, or abdominal pain, measures on 100mm visual analog scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026