Noninvasive Diagnostic Tests for Nausea

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Claustrophobia, Intestinal complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses noninvasive tests to measure stomach activity in adolescents with functional nausea. By capturing the stomach's electrical and magnetic signals, doctors aim to better understand and diagnose this condition. A noninvasive technique has been used to measure stomach activity and evaluate symptoms like nausea.

Research Team

Alan Bradshaw, Ph.D.

Principal Investigator

Vanderbilt University

Eligibility Criteria

This trial is for children aged 8-17 who either experience functional nausea or are healthy controls without gastrointestinal issues. It excludes those with claustrophobia, cardiac arrhythmias, severe obesity, cyclic vomiting syndrome, gastroparesis, cancer, eating disorders, pregnancy or hyperglycemia.

Inclusion Criteria

My child, aged 8-17, frequently experiences nausea without a clear cause.

I am between 8-17 years old and do not have any known stomach or intestine problems.

Exclusion Criteria

I do not have a history of heart rhythm problems and am not on blood thinners.

You are very overweight and may not fit properly in the equipment used for the study.

I do not have cyclic vomiting, gastroparesis, cancer, eating disorders, am not pregnant, and do not have high blood sugar.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants undergo EGG and MGG testing, questionnaires, and EKG after an overnight fast. Testing includes response to a protein bar and, for some, ondansetron and cyproheptadine administration.

6 months

Follow-up

Participants are monitored for changes in nausea parameters and slow wave activity.

4 weeks

Treatment Details

Interventions

• 36 channel high resolution electrogastrogram (HR-EGG)
• 4 channel electrogastrogram (EGG)
• Cyproheptadine Oral Tablet
• Electrocardiogram (EKG)
• Magnetogastrogram (MGG)
• Ondansetron
• Questionnaires

Trial Overview The study aims to identify noninvasive markers of functional nausea using questionnaires and various recording techniques like EGG and MGG. Medications Ondansetron and Cyproheptadine will also be evaluated in this pediatric population.

Participant Groups

Group I: Moderately nauseated Active Control 5 Interventions

Functional nausea patients with a score of 5-6 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.

Group II: Severely nauseated Active Control 7 Interventions

Functional nausea patients with a score of 7-9 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar. Some patients will also be tested after receiving a one time dose of a 4mg or 8mg dependent upon age disintegrating tablet of ondansetron followed by a 2 day washout period prior to testing again after a 5 day maintenance dose of oral cyproheptadine 4mg twice a day.

Group III: Healthy Controls Active Control 5 Interventions

Healthy Volunteers with no known gastrointestinal complications will be given questionnaires and testing by electrogastrogram (EGG) and/or magnetogastrogram (MGG) after an overnight fast to determine nausea parameters. They will also have a electrocardiogram (EKG) and do some testing after being fed a protein bar.

Group IV: Non-nauseated Active Control 5 Interventions

Functional nausea patients with a score of 0-2 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.

Group V: Mildly nauseated Active Control 5 Interventions

Functional nausea patients with a score of 3-4 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+