What is the mechanism of action of this treatment?

Common treatments for nausea include antiemetics such as 5HT3 antagonists, phenothiazines, and antihistamines. 5HT3 antagonists work by blocking serotonin receptors in the gut and brain, reducing nausea and vomiting. Phenothiazines act on dopamine receptors in the brain to inhibit nausea signals, while antihistamines block histamine receptors that can trigger nausea. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific type of nausea, potentially improving efficacy and reducing side effects. Studies using Multichannel Electrogastrogram (EGG) and Magnetogastrogram (MGG) recordings aim to better characterize gastric electrical and magnetic activity, which can lead to more precise and effective treatments for nausea.

What side effects are associated with this type of intervention?

Common treatments for nausea that involve modulation of gastric electrical activity include gastric electrical stimulation (GES) and medications like metoclopramide. GES can cause mild side effects such as abdominal discomfort, nausea, and vomiting. Metoclopramide, a prokinetic agent, can lead to side effects including drowsiness, fatigue, and, in rare cases, more severe reactions like tardive dyskinesia. Non-invasive treatments like EGG and MGG recordings themselves are generally safe and primarily used for diagnostic purposes without significant side effects.

What prior FDA approvals exist?

The FDA has approved several antiemetic drugs for the treatment of nausea, including serotonin receptor antagonists (e.g., ondansetron, granisetron, dolasetron), which are effective but may cause electrocardiographic changes. Phenothiazines and antihistamines are also approved and can be administered orally, parenterally, or rectally. These treatments are relevant to studies using multichannel electrogastrogram (EGG) and magnetogastrogram (MGG) recordings, which characterize gastric electrical and magnetic activity to better understand and treat functional nausea.

What other types of research exist?

Promising novel alternatives to Multichannel Electrogastrogram (EGG) and Magnetogastrogram (MGG) recordings for nausea patients include wireless motility capsules, which provide a non-invasive method to measure gastric emptying and gastrointestinal transit times. Additionally, advancements in impedance-pH monitoring can offer detailed insights into both acid and non-acid reflux, which may contribute to nausea symptoms. These technologies are gaining traction due to their ability to provide comprehensive diagnostic information with minimal patient discomfort.

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Noninvasive Diagnostic Tests for Nausea

N/A

Waitlist Available

Led By Alan Bradshaw, Ph.D.

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

normal control participants ages 8-17 who have no known gastrointestinal complications

Be younger than 18 years old

Must not have

Normal participants with known intestinal complications

Patients with cyclic vomiting syndrome, gastroparesis, malignancy, primary eating disorders, pregnancy, or hyperglycemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the medications include headaches, constipation or diarrhea (Ondansetron), and drowsiness or dry mouth (Cyproheptadine). The recording procedures are generally safe but may cause discomfort due to lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a healthy body but with known gut issues.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Normal Slow Waves (PNSW)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Active Control

Group I: Moderately nauseatedActive Control5 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 nauseatedActive Control7 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 ControlsActive Control5 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-nauseatedActive Control5 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 nauseatedActive Control5 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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for nausea include antiemetics such as 5HT3 antagonists, phenothiazines, and antihistamines. 5HT3 antagonists work by blocking serotonin receptors in the gut and brain, reducing nausea and vomiting. Phenothiazines act on dopamine receptors in the brain to inhibit nausea signals, while antihistamines block histamine receptors that can trigger nausea. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific type of nausea, potentially improving efficacy and reducing side effects. Studies using Multichannel Electrogastrogram (EGG) and Magnetogastrogram (MGG) recordings aim to better characterize gastric electrical and magnetic activity, which can lead to more precise and effective treatments for nausea.

New device for active gastric mechanical stimulation.Electrogastrography in adults and children: the strength, pitfalls, and clinical significance of the cutaneous recording of the gastric electrical activity.[Clinical observation on effect of weichangshu in treating diabetic gastroparesis].