Noninvasive Markers of Functional Nausea in Children

Vanderbilt University Medical Center

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Nausea

Treatments: Diagnostic Test: Questionnaires; Diagnostic Test: 4 channel electrogastrogram (EGG); Diagnostic Test: Magnetogastrogram (MGG); Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG); Drug: Cyproheptadine Oral Tablet; Drug: Ondansetron; Diagnostic Test: Electrocardiogram (EKG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03593811

162035

Details and patient eligibility

About

The researchers propose to study how functional nausea in adolescents may be characterized noninvasively by the use of multichannel electrogastrogram (EGG) and magnetogastrogram (MGG) recordings.

Full description

5/23/25. Study record updated to reflect Early Phase I trial as opposed to "N/A". The main aims were to develop a mathematical model of FN, correlate functional differences in slow waves in FN patients using modeling and experimental approaches, and to characterize biophysical, clinical, and psychosocial phenotypes of FN using newly developed diagnostic devices of EGG/MGG.

Functional nausea (FN) is a GI disorder that affects millions of Americans, particularly adolescents, but diagnoses remain largely exclusionary relying on symptomology with an otherwise normal diagnostic workup.

Successful completion of the project could contribute to understanding the altered physiology of functional nausea (FN), to stratification of FN patients according to physiological and/or psychological phenotypes, to improve diagnosis and provide objective measures of nausea and to inform and guide treatment options.

The analysis of slow wave activity represents the first physiologically-quantifiable noninvasive assessment method for pathological processes associated with functional nausea in adolescents.

Enrollment: 42 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children ages 8-17 with functional nausea
• normal control participants ages 8-17 who have no known gastrointestinal complications

Exclusion criteria

• Those with claustrophobia who cannot lie still under the SQUID for the length of time required.
• Normal participants with known intestinal complications
• Patients with cyclic vomiting syndrome, gastroparesis, malignancy, primary eating disorders, pregnancy, or hyperglycemia
• Morbid obesity (these patients are presumably unable to lie under the current generation of SQUID devices).
• Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 5 patient groups

Healthy Controls

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Electrocardiogram (EKG)

Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG)

Diagnostic Test: Magnetogastrogram (MGG)

Diagnostic Test: 4 channel electrogastrogram (EGG)

Diagnostic Test: Questionnaires

Non-nauseated

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Electrocardiogram (EKG)

Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG)

Diagnostic Test: Magnetogastrogram (MGG)

Diagnostic Test: 4 channel electrogastrogram (EGG)

Diagnostic Test: Questionnaires

Mildly nauseated

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Electrocardiogram (EKG)

Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG)

Diagnostic Test: Magnetogastrogram (MGG)

Diagnostic Test: 4 channel electrogastrogram (EGG)

Diagnostic Test: Questionnaires

Moderately nauseated

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Electrocardiogram (EKG)

Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG)

Diagnostic Test: Magnetogastrogram (MGG)

Diagnostic Test: 4 channel electrogastrogram (EGG)

Diagnostic Test: Questionnaires

Severely nauseated

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Electrocardiogram (EKG)

Drug: Ondansetron

Drug: Cyproheptadine Oral Tablet

Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG)

Diagnostic Test: Magnetogastrogram (MGG)

Diagnostic Test: 4 channel electrogastrogram (EGG)

Diagnostic Test: Questionnaires