We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00728026
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Vomiting Syndrome Irritable Bowel Syndrome Postural Orthostatic Tachycardia Syndrome Abdominal Pain Chronic Nausea

Study Design

Study Type : Observational
Actual Enrollment : 19 participants
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
Study Start Date : June 2008
Primary Completion Date : September 16, 2016
Study Completion Date : September 16, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Cyclic Vomiting Syndrome
2
Irritable Bowel Syndrome
3
Postural Orthostatic Tachycardia Syndrome
4
Functional Abdominal Pain
5
Chronic Nausea


Outcome Measures

Primary Outcome Measures :
  1. To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders. [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by B Li, 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:
Syndrome
Irritable Bowel Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Nausea
Vomiting
Abdominal Pain
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases