Applying Nutrient Drink Test in Understanding Pathophysiology of CVS

NCT03470181 | Completed

• 1 other identifier: 17-1138
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cyclic Vomiting Syndrome

Keywords

Chronic nausea, intermittent vomiting, impaired accommodation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Aggregate Symptom Score

  Within 30 minutes of the beginning of the test

Study Arms (2)

Participants with Diagnosed CVS

This cohort will consist of 15 current patients previously diagnosed with Cyclic Vomiting Syndrome.

Dietary Supplement: Ensure

Healthy Volunteers

This cohort will consist of 15 healthy volunteers, with no history of Cyclic Vomiting.

Dietary Supplement: Ensure

Interventions

Ensure DIETARY_SUPPLEMENT

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

Healthy Volunteers; Participants with Diagnosed CVS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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®

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Familial cyclic vomiting syndrome

Study Officials

• Scott Gabbard, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: February 1, 2018
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)