Applying Nutrient Drink Test in Understanding Pathophysiology of CVS

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.

Study Overview

• Status: Completed
• Conditions: Cyclic Vomiting Syndrome
• Intervention / Treatment: Dietary supplement: Ensure

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study seeks to enroll adult patients diagnosed with Cyclic Vomiting Syndrome, as well as healthy controls

Description

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®

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Diagnosed CVS; This cohort will consist of 15 current patients previously diagnosed with Cyclic Vomiting Syndrome.	Dietary supplement: Ensure; Participants will perform a Nutrient Drink Test. This consists of drinking 125mL of liquid Ensure four times, at five-minute intervals.
Healthy Volunteers; This cohort will consist of 15 healthy volunteers, with no history of Cyclic Vomiting.	Dietary supplement: Ensure; Participants will perform a Nutrient Drink Test. This consists of drinking 125mL of liquid Ensure four times, at five-minute intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated volume	The amount of nutrient drink consumed before the participant reports feelings of unbearable fullness.	Within 30 minutes of beginning the test.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Aggregate Symptom Score	Participant-Reported impressions of fullness, bloating, or abdominal pain, measures on 100mm visual analog scale	Within 30 minutes of the beginning of the test

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Scott Gabbard, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): May 29, 2018
• Study Completion (ACTUAL): May 29, 2018

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (ACTUAL): March 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Chronic nausea, intermittent vomiting, impaired accommodation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Signs and Symptoms, Digestive; Syndrome; Vomiting
• Other Study ID Numbers: 17-1138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No