- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00728026
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
August 10, 2017 updated by: B Li, Medical College of Wisconsin
Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Functional Abdominal Pain or Chronic Nausea
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
19
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
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)
Description
Inclusion Criteria:
- Outpatient services
Exclusion Criteria:
- Inpatient services
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: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
1
Cyclic Vomiting Syndrome
|
2
Irritable Bowel Syndrome
|
3
Postural Orthostatic Tachycardia Syndrome
|
4
Functional Abdominal Pain
|
5
Chronic Nausea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders.
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: B UK Li, 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
June 1, 2008
Primary Completion (Actual)
September 16, 2016
Study Completion (Actual)
September 16, 2016
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)
August 14, 2017
Last Update Submitted That Met QC Criteria
August 10, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Disease
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Orthostatic Intolerance
- Syndrome
- Nausea
- Vomiting
- Irritable Bowel Syndrome
- Abdominal Pain
- Tachycardia
- Postural Orthostatic Tachycardia Syndrome
Other Study ID Numbers
- 08/112
- GC 680
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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