Vomiting SyndromeNCT00728026
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
An observational study of Vomiting Syndrome and Irritable Bowel Syndrome, run by Medical College of Wisconsin.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to 16 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Diagnosis of either: Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS), Chronic nausea, Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP)
Who may be able to join
- Outpatient services
Who cannot join
- Inpatient services
About this study
Official title: 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.
- 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
- Medical subject headings
- Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cyclic Vomiting Syndrome | |
| 2 | Irritable Bowel Syndrome | |
| 3 | Postural Orthostatic Tachycardia Syndrome | |
| 4 | Functional Abdominal Pain | |
| 5 | Chronic Nausea |
What is being measured
The primary outcome is the main question the study is designed to answer.
To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startJun 2008
- Primary completion16 Sep 2016
- Study completion16 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vomiting SyndromeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, B Li, Medical College of Wisconsin
- Investigators
- B UK Li, Principal investigator, Medical College of Wiconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728026
- Sponsor's protocol ID
- 08/112
- Other IDs
- GC 680
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2008
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Functional Abdominal Pain or Chronic Nausea
- ClinicalTrials.gov ID
- NCT00728026
- Acronym / sponsor ID
- 08/112
- 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,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Jun 2008
- Primary completion
- 16 Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Cyclic Vomiting Syndrome |
| 2 | – | –Irritable Bowel Syndrome |
| 3 | – | –Postural Orthostatic Tachycardia Syndrome |
| 4 | – | –Functional Abdominal Pain |
| 5 | – | –Chronic Nausea |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diagnosis of either: Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS), Chronic nausea, Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP)
Key inclusion criteria (1 listed)
- Outpatient services
Key exclusion criteria (1 listed)
- Inpatient services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
Related trials for Vomiting Syndrome
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
Cortical Excitability in Cyclic Vomiting Syndrome
Cyclic Vomiting Syndrome
Recruiting
Brain-Stomach Circuits in Chronic Nausea
Chronic Nausea and Vomiting Syndrome
Recruiting
Evaluating Whether a Nausea Band Reduces Symptoms in Those With Chronic Nausea Vomiting
Chronic Nausea, Chronic Nausea and Vomiting Syndrome
RecruitingObservational study
Indiana University Gastrointestinal Motility Diagnosis Registry
Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B UK Li principal investigator
Medical College of Wiconsin
Questions about this trial
What is this clinical trial studying?
An observational study of Vomiting Syndrome and Irritable Bowel Syndrome, run by Medical College of Wisconsin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.