Autonomic Profiles in Pediatric Patients With Cyclic Vomi... | NCT00728026

Studies
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

NCT00728026

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Aug 14, 2017Actual

Enrollment

19Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
GC 680

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Sep 16, 2016Actual

Completion Date

Sep 16, 2016Actual

First Submitted Date

Jul 31, 2008

First Submission Date that Met QC Criteria

Aug 4, 2008

First Posted Date

Aug 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2017

Last Update Posted Date

Aug 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

B Li, Professor of Pediatrics, Medical College of WisconsinPrincipal Investigator

Lead Sponsor

Medical College of WisconsinOTHER

Collaborators

Name	Class
Children's Hospital and Health System Foundation, Wisconsin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

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

Keywords

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Cyclic Vomiting Syndrome
2		Irritable Bowel Syndrome
3		Postural Orthostatic Tachycardia Syndrome
4		Functional Abdominal Pain
5		Chronic Nausea

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders.		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatient services

Exclusion Criteria:

Inpatient services

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
B UK Li	Medical College of Wiconsin	Principal Investigator

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

United States

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D043183	Irritable Bowel Syndrome
D054972	Postural Orthostatic Tachycardia Syndrome
D015746	Abdominal Pain

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive