Genetic Analysis of Children With Cyclic Vomiting Syndrome (CVS) and Migraines

December 23, 2019 updated by: Katja Kovacic, Medical College of Wisconsin

Genetic Analysis of Children With Cyclic Vomiting Syndrome and Migraines

The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS).

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS), various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine). This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with CVS.

Study Type

Observational

Enrollment (Actual)

586

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cyclic vomiting syndrome (CVS) may be the most severe recurrent vomiting disorder in humans. CVS is characterized by a sudden onset of rapid-fire vomiting, usually beginning in the early morning hours or upon wakening. It has a peak vomiting intensity of every 5-10 minutes (6-12 emeses) and episodes last between 2 hours and 10 days. These episodes of acute vomiting occur on average once every 2 to 4 weeks. The child returns to completely normal health between vomiting episodes. Children are diagnosed based on their specific vomiting pattern and a lack of positive findings on laboratory testing.

Description

Inclusion Criteria:

  • Subjects age 0-21 years old with CVS (different phenotypes). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent.

Exclusion Criteria:

  • Subjects age > 22 years old Vomiting is not due to CVS or other related condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1

Diagnostic Criteria for CVS:

3 or more different episodes of vomiting, normal health between episodes, no abnormal test results to account for vomiting [such as endoscopic biopsies (looking at a body part with a lighted tube), hydronephrosis (water block kidney drainage), cholelithiasis (gallstones), pancreatitis (swelling of the pancreas), and hypoglycemia (too little sugar in the blood)];
2

Diagnostic Criteria for Migraine:

5 or more different headaches, complete return to health in between headaches, headaches last 2-48 hours and get in the way everyday activity, headache affects one side of head, with pounding moderate-to-severe pain, one of the following: nausea, vomiting, photophobia (fear of light), phonophobia (fear of sound).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Perform genotype-phenotype correlations between genetic profiles and various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

Children's Hospital and Health System Foundation, Wisconsin

Investigators

  • Principal Investigator: Katja Kovacic, MD, Medical College of Wiconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2008

Primary Completion (Actual)

June 12, 2013

Study Completion (Actual)

June 12, 2013

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/24
  • GC 607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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