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Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00728026
First received: July 31, 2008
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

Retrospectively review the charts of all children who had heart rate variability, deep breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing, quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's Hospital of Wisconsin.


Condition
Vomiting Syndrome
Irritable Bowel Syndrome
Postural Orthostatic Tachycardia Syndrome
Abdominal Pain
Chronic Nausea

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Functional Abdominal Pain or Chronic Nausea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Cyclic Vomiting Syndrome
2
Irritable Bowel Syndrome
3
Postural Orthostatic Tachycardia Syndrome
4
Functional Abdominal Pain
5
Chronic Nausea

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diagnosis of either: Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS), Chronic nausea, Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP)

Criteria

Inclusion Criteria:

  • Outpatient services

Exclusion Criteria:

  • Inpatient services
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728026

Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: B UK Li Medical College of Wiconsin
  More Information

No publications provided

Responsible Party: B Li, Professor of Pediatrics, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00728026     History of Changes
Other Study ID Numbers: 08/112, GC 680
Study First Received: July 31, 2008
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Chart must reveal the following procedures:
Heart rate variability,
Deep Breathing Test,
Valsalva maneuver,
Table test,
 Thermoregulatory Sweat Testing,
Quantitative Sudomotor Axon Reflex Test (QSART),
Vital signs,
postural changes in heart rate and blood pressure,
composite autonomic score

Additional relevant MeSH terms:
Abdominal Pain
Irritable Bowel Syndrome
Nausea
Tachycardia
Vomiting
Postural Orthostatic Tachycardia Syndrome
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013