Applying Nutrient Drink Test in Understanding Pathophysiology of CVS

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.

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Key information

Conditions

Cyclic Vomiting Syndrome Familial cyclic vomiting syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Ensure

Dietary Supplement

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

Primary outcomes

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.

Secondary outcomes

Total Aggregate Symptom Score

Time frame: Within 30 minutes of the beginning of the test

Participant-Reported impressions of fullness, bloating, or abdominal pain, measures on 100mm visual analog scale

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Applying Nutrient Drink Test in Understanding Pathophysiology of Cyclic Vomiting Syndrome

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Mar 19, 2018
Registry last updated: Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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