Cyclic Vomiting SyndromeNCT07465614
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
A study testing Active percutaneous electrical nerve field stimulation in people with Cyclic Vomiting Syndrome, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Cyclic vomiting syndrome (CVS) is a fairly common disorder characterized by relentless episodes of vomiting followed by return to baseline health.The majority of children with CVS have concurrent severe abdominal pain and migraine-features, causing significant disability during the attacks. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cyclic Vomiting Syndrome
- What is being tested?
- Active percutaneous electrical nerve field stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Episodic vomiting that meet criteria for CVS based on the 2025 NASPGHAN guidelines for diagnosis of pediatric CVS
- English-speaking
- Lack of other explanation for vomiting
- Intact external ear that is free of infection or severe dermatological conditions
- Stable stable vital signs for their respective age
- No currently implanted electrical device
- Family able to accurately describe symptoms and number of vomiting episodes
- At least 2 vomiting episodes during the 6 months prior to enrollment
Who cannot join
- Medically complex children or those who take a medication or suffer from another active disease that explain symptoms
- Children or their parents who have significant developmental delay
- Participants diagnosed with alternate conditions that explains their symptoms after undergoing medical workup per standard of care
- Patients with findings of active disease such as intestinal malrotation, peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, hydronephrosis, metabolic disorder or any other active chronic condition or medication that may cause of vomiting
- Patients who are treated with a new drug affecting the central nervous system in the 4 weeks prior to enrollment
- Pregnancy
Show all 9Show fewer
- Severe cardiopulmonary diseases such as chronic obstructive pulmonary disease (COPD) or coronary artery disease
- Current chronic marijuana use defined as marijuana use > 2 times per week over the last 6 months prior to study enrollment
- Previously treated with a PENFS device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Lisa Nielson, BS, 4142663695, lnielson@mcw.edu
About this study
Official title: Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome: A Randomized, Sham Controlled Trial
Cyclic vomiting syndrome (CVS) is a fairly common disorder characterized by relentless episodes of vomiting followed by return to baseline health.The majority of children with CVS have concurrent severe abdominal pain and migraine-features, causing significant disability during the attacks. There are very few non-drug treatment options for CVS. Many patients are treated with antidepressants that are often ineffective and may cause serious side effects. Emergency room visits and hospitalizations for patients with CVS is extremely high and the syndrome has an immense impact on quality of life. Safe and effective, non-pharmacological therapies for children with CVS are greatly needed.
Nausea, vomiting and gastrointestinal pain is modulated by the vagus nerve, an important regulator of the autonomic nervous system. The vagus communicates signals between the gastrointestinal tract and the central nervous system. Many studies indicate that vagal nerve stimulation is effective for various pain and vomiting conditions. Recent studies show that vagus nerve signaling is impaired in children with CVS. Researchers have demonstrated safety and efficacy of auricular percutaneous electrical nerve field stimulation (PENFS) targeting the vagus nerve in a small study of children with CVS. The aim of the current study is to investigate the effects of non-invasive PENFS on CVS episode frequency, duration and severity compared to a sham device in a randomized clinical trial.
Read the detailed description
Cyclic vomiting syndrome (CVS) is a disorder of gut-brain interaction characterized by severe, stereotypical and disabling episodes of intense nausea and vomiting, lasting anywhere from 2 hours to 7 days. The disorder is more prevalent than commonly recognized and is estimated to occur in 1.9% of children. The medical costs for the diagnosis and treatment of CVS are immense and quality of life is markedly affected and worse in children with CVS compared to other gut-brain disorders.
About 80% of patients with CVS suffer from concurrent migraine headaches or abdominal migraines during the episodes. Therapies are therefore targeted both towards both nausea and vomiting and aggressive pain control. Therapies are empiric, and response is often variable with numerous patients still requiring Emergency Room visits or hospital admissions. Tricyclic antidepressants are traditionally the most commonly used "off-label" drugs for children with CVS. These drugs may cause serious side effects, and are frequently discontinued due to intolerable adverse effects. Most recent CVS treatment guidelines in fact call for use of these antidepressants only in refractory cases and instead, increased use of non-pharmacological interventions in all children with CVS. Safer and more effective treatments for children with CVS are much needed. Currently, there are no FDA-approved drugs for the treatment of CVS in children.
The mechanisms underlying CVS remain unclear but there is emerging consensus of altered brain-gut neurocircuitry and autonomic nervous system imbalance. Autonomic abnormalities are previously documented in both children and adults with CVS. Researchers have recently demonstrated significantly altered dynamic, cardiac vagal function in children with CVS compared to age and size matched healthy controls, supporting the use of interventions that target vagal signaling.
Interventions targeting the underlying autonomic imbalance such as auricular vagal nerve stimulation are likely targeting the underlying autonomic imbalance via stimulation of the auricular branch of the vagus in the outer ear. The ear is innervated by several cranial nerves including the vagus (CN X) which projects directly to brainstem nausea and vomiting centers. Stress and elevated sympathetic nervous system activity may contribute to initiation of vomiting in CVS patients and therapy via vagal modulation may alter these signals and prevent episodes.
Non-invasive, auricular neurostimulation using the percutaneous electrical nerve field stimulation (PENFS) device has been demonstrated effective for gastrointestinal pain in a randomized, sham controlled clinical trial. More recently, PENFS was demonstrated effective in an open-label, prospective pilot study of 30 children with drug-refractory CVS. There was a significant improvement in both frequency and duration of CVS episodes from baseline (p<0.0001). Notably, a positive effect on quality of life was demonstrated at long-term follow-up after only 6 weeks of therapy. At 6 months follow-up, 80% demonstrated at least 50% improvement in either frequency or duration of episodes with a median response duration of 113 days. Importantly, 100% of these patients were satisfied with the treatment and no serious side effects were reported. Auricular neurostimulation thus modulates autonomic nervous system balance, thereby improving nausea and vomiting presumably by altering vagal signaling with secondary effects of improving quality of life.
The aim of this study is to further investigate the efficacy of auricular neurostimulation using PENFS in a randomized, sham controlled study design in a large cohort of children with CVS. Children ages 5-18 years, evaluated at Children's Wisconsin hospital gastroenterology clinic and meeting formal criteria for CVS based on 2025 NASPGHAN guidelines may be eligible to participate. Subjects will be randomized 2:1 to receive 5 consecutive weeks of active or sham PENFS therapy in a blinded fashion. Subjects will be followed for 12 months after completion of therapy.
- Conditions
- Cyclic Vomiting Syndrome
- Being tested
- Active percutaneous electrical nerve field stimulation, Sham percutaneous electrical nerve field stimulation
- Keywords
- auricular neurostimulation, vagus nerve stimulation, cyclic vomiting syndrome in children
- Medical subject headings
- Familial cyclic vomiting syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active percutaneous electrical nerve field stimulationDevice
Also called IB-stim
Auricular vagus nerve stimulation using an percutaneously placed, active device that is worn for 5 days/week for several consecutive weeks
Sham percutaneous electrical nerve field stimulationDevice
Also called IB-stim
Auricular vagus nerve stimulation using a sham device that is percutaneously placed on the wear and worn for 5 days/week for several consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Percutaneous Electrical Nerve Field Stimulation (PENFS) | Experimental | Active PENFS device x 5 consecutive weeks Receives: Device: Active percutaneous electrical nerve field stimulation |
| Sham Percutaneous Electrical Nerve Field Stimulation (PENFS) | Sham comparator | Sham PENFS device x 5 consecutive weeks Receives: Device: Sham percutaneous electrical nerve field stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyclic Vomiting Syndrome Burden Index
A 5-item survey assessing the frequency, duration and severity of CVS attacks with scores ranging from minimum 0 to maximum 25 and higher score indicating worse outcome.
Measured: From enrollment (baseline) to 6 months after end of treatment
Secondary outcomes (2)
Pediatric Migraine Disability Assessment (PedMIDAS)
8-item questionnaire designed to assess disability associated with migraine conditions. Total score ranges from minimum 0 (no disability) to >50 (severe disability) with higher scores indicating worse outcome.
Measured: From enrollment (baseline) to 6 months after end of therapy
Symptom Response Scale
Assessment of global symptom response based on a 15-point scale with score ranging from minimum -7 to maximum +7 (0=no change). Higher scores indicate improved outcome.
Measured: From enrollment (baseline) to 6 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start11 Feb 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cyclic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized 2:1 to active vs sham therapy arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gila Ginzburg, Medical College of Wisconsin
- Investigators
- Gila Ginzburg, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465614
- Sponsor's protocol ID
- PRO00055846
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified IPD such as patient reported outcome survey data may be shared with other researchers upon request
Publications
Karrento K, Rosen JM, Tarbell SE, Issenman RM, Gelfand AA, Gamboa H, Parikh S, Adams K, Wiercioch W, Li BUK. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 2025 guidelines for management of cyclic vomiting syndrome in children. J Pediatr Gastroenterol Nutr. 2025 Jun;80(6):1028-1061. doi: 10.1002/jpn3.70020. Epub 2025 Apr 14.
PubMed 40223700Karrento K, Rosen JM, Gelfand AA, Parikh S, Tarbell SE, Issenman RM, Gamboa H, Adams K, Wiercioch W, Li BUK. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 2025 guidelines on the diagnosis of cyclic vomiting syndrome in children. J Pediatr Gastroenterol Nutr. 2025 Nov;81(5):1346-1359. doi: 10.1002/jpn3.70193. Epub 2025 Aug 20.
PubMed 40836301Karrento K, Venkatesan T, Zhang L, Pawela L, Simpson P, Li BUK. Percutaneous Electrical Nerve Field Stimulation for Drug-Refractory Pediatric Cyclic Vomiting Syndrome. J Pediatr Gastroenterol Nutr. 2023 Sep 1;77(3):347-353. doi: 10.1097/MPG.0000000000003876. Epub 2023 Jun 26.
PubMed 37364137Kolacz J, Kovacic K, Dang L, Li BUK, Lewis GF, Porges SW. Cardiac Vagal Regulation Is Impeded in Children With Cyclic Vomiting Syndrome. Am J Gastroenterol. 2023 Jul 1;118(7):1268-1275. doi: 10.14309/ajg.0000000000002207. Epub 2023 Jan 30.
PubMed 36716443
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome: A Randomized, Sham Controlled Trial
- ClinicalTrials.gov ID
- NCT07465614
- Acronym / sponsor ID
- PRO00055846
- Conditions
- Cyclic Vomiting Syndrome
- Keywords
- auricular neurostimulation, vagus nerve stimulation, cyclic vomiting syndrome in children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- 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.
Cyclic vomiting syndrome (CVS) is a fairly common disorder characterized by relentless episodes of vomiting followed by return to baseline health.The majority of children with CVS have concurrent severe abdominal pain and migraine-features, causing significant disability during the attacks. There are very few non-drug treatment options for CVS. Many patients are treated with antidepressants that are often ineffective and may cause serious side effects. Emergency room visits and hospitalizations for patients with CVS is extremely high and the syndrome has an immense impact on quality of life. Safe and effective, non-pharmacological therapies for children with CVS are greatly needed.
Nausea, vomiting and gastrointestinal pain is modulated by the vagus nerve, an important regulator of the autonomic nervous system. The vagus communicates signals between the gastrointestinal tract and the central nervous system. Many studies indicate that vagal nerve stimulation is effective for various pain and vomiting conditions. Recent studies show that vagus nerve signaling is impaired in children with CVS. Researchers have demonstrated safety and efficacy of auricular percutaneous electrical nerve field stimulation (PENFS) targeting the vagus nerve in a small study of children with CVS. The aim of the current study is to investigate the effects of non-invasive PENFS on CVS episode frequency, duration and severity compared to a sham device in a randomized clinical trial.
Detailed description
Cyclic vomiting syndrome (CVS) is a disorder of gut-brain interaction characterized by severe, stereotypical and disabling episodes of intense nausea and vomiting, lasting anywhere from 2 hours to 7 days. The disorder is more prevalent than commonly recognized and is estimated to occur in 1.9% of children. The medical costs for the diagnosis and treatment of CVS are immense and quality of life is markedly affected and worse in children with CVS compared to other gut-brain disorders.
About 80% of patients with CVS suffer from concurrent migraine headaches or abdominal migraines during the episodes. Therapies are therefore targeted both towards both nausea and vomiting and aggressive pain control. Therapies are empiric, and response is often variable with numerous patients still requiring Emergency Room visits or hospital admissions. Tricyclic antidepressants are traditionally the most commonly used "off-label" drugs for children with CVS. These drugs may cause serious side effects, and are frequently discontinued due to intolerable adverse effects. Most recent CVS treatment guidelines in fact call for use of these antidepressants only in refractory cases and instead, increased use of non-pharmacological interventions in all children with CVS. Safer and more effective treatments for children with CVS are much needed. Currently, there are no FDA-approved drugs for the treatment of CVS in children.
The mechanisms underlying CVS remain unclear but there is emerging consensus of altered brain-gut neurocircuitry and autonomic nervous system imbalance. Autonomic abnormalities are previously documented in both children and adults with CVS. Researchers have recently demonstrated significantly altered dynamic, cardiac vagal function in children with CVS compared to age and size matched healthy controls, supporting the use of interventions that target vagal signaling.
Interventions targeting the underlying autonomic imbalance such as auricular vagal nerve stimulation are likely targeting the underlying autonomic imbalance via stimulation of the auricular branch of the vagus in the outer ear. The ear is innervated by several cranial nerves including the vagus (CN X) which projects directly to brainstem nausea and vomiting centers. Stress and elevated sympathetic nervous system activity may contribute to initiation of vomiting in CVS patients and therapy via vagal modulation may alter these signals and prevent episodes.
Non-invasive, auricular neurostimulation using the percutaneous electrical nerve field stimulation (PENFS) device has been demonstrated effective for gastrointestinal pain in a randomized, sham controlled clinical trial. More recently, PENFS was demonstrated effective in an open-label, prospective pilot study of 30 children with drug-refractory CVS. There was a significant improvement in both frequency and duration of CVS episodes from baseline (p<0.0001). Notably, a positive effect on quality of life was demonstrated at long-term follow-up after only 6 weeks of therapy. At 6 months follow-up, 80% demonstrated at least 50% improvement in either frequency or duration of episodes with a median response duration of 113 days. Importantly, 100% of these patients were satisfied with the treatment and no serious side effects were reported. Auricular neurostimulation thus modulates autonomic nervous system balance, thereby improving nausea and vomiting presumably by altering vagal signaling with secondary effects of improving quality of life.
The aim of this study is to further investigate the efficacy of auricular neurostimulation using PENFS in a randomized, sham controlled study design in a large cohort of children with CVS. Children ages 5-18 years, evaluated at Children's Wisconsin hospital gastroenterology clinic and meeting formal criteria for CVS based on 2025 NASPGHAN guidelines may be eligible to participate. Subjects will be randomized 2:1 to receive 5 consecutive weeks of active or sham PENFS therapy in a blinded fashion. Subjects will be followed for 12 months after completion of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects randomized 2:1 to active vs sham therapy arms
| Arm | Type | Receives |
|---|---|---|
| Active Percutaneous Electrical Nerve Field Stimulation (PENFS) | Experimental | Device: Active percutaneous electrical nerve field stimulationActive PENFS device x 5 consecutive weeks |
| Sham Percutaneous Electrical Nerve Field Stimulation (PENFS) | Sham comparator | Device: Sham percutaneous electrical nerve field stimulationSham PENFS device x 5 consecutive weeks |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Episodic vomiting that meet criteria for CVS based on the 2025 NASPGHAN guidelines for diagnosis of pediatric CVS
- English-speaking
- Lack of other explanation for vomiting
- Intact external ear that is free of infection or severe dermatological conditions
- Stable stable vital signs for their respective age
Key exclusion criteria (9 listed)
- Medically complex children or those who take a medication or suffer from another active disease that explain symptoms
- Children or their parents who have significant developmental delay
- Participants diagnosed with alternate conditions that explains their symptoms after undergoing medical workup per standard of care
- Patients with findings of active disease such as intestinal malrotation, peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, hydronephrosis, metabolic disorder or any other active chronic condition or medication that may cause of vomiting
- Patients who are treated with a new drug affecting the central nervous system in the 4 weeks prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active percutaneous electrical nerve field stimulationAlso: IB-stimAuricular vagus nerve stimulation using an percutaneously placed, active device that is worn for 5 days/week for several consecutive weeks | Device | Active Percutaneous Electrical Nerve Field Stimulation (PENFS) |
| Sham percutaneous electrical nerve field stimulationAlso: IB-stimAuricular vagus nerve stimulation using a sham device that is percutaneously placed on the wear and worn for 5 days/week for several consecutive weeks | Device | Sham Percutaneous Electrical Nerve Field Stimulation (PENFS) |
Primary outcome
Cyclic Vomiting Syndrome Burden Index
Time frame: From enrollment (baseline) to 6 months after end of treatment
A 5-item survey assessing the frequency, duration and severity of CVS attacks with scores ranging from minimum 0 to maximum 25 and higher score indicating worse outcome.
2 secondary outcomes
Pediatric Migraine Disability Assessment (PedMIDAS)
Time frame: From enrollment (baseline) to 6 months after end of therapy
Symptom Response Scale
Time frame: From enrollment (baseline) to 6 months after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 40223700Karrento K, Rosen JM, Tarbell SE, Issenman RM, Gelfand AA, Gamboa H, Parikh S, Adams K, Wiercioch W, Li BUK. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 2025 guidelines for management of cyclic vomiting syndrome in children. J Pediatr Gastroenterol Nutr. 2025 Jun;80(6):1028-1061. doi: 10.1002/jpn3.70020. Epub 2025 Apr 14.
- Background: PubMed 40836301Karrento K, Rosen JM, Gelfand AA, Parikh S, Tarbell SE, Issenman RM, Gamboa H, Adams K, Wiercioch W, Li BUK. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 2025 guidelines on the diagnosis of cyclic vomiting syndrome in children. J Pediatr Gastroenterol Nutr. 2025 Nov;81(5):1346-1359. doi: 10.1002/jpn3.70193. Epub 2025 Aug 20.
- Background: PubMed 37364137Karrento K, Venkatesan T, Zhang L, Pawela L, Simpson P, Li BUK. Percutaneous Electrical Nerve Field Stimulation for Drug-Refractory Pediatric Cyclic Vomiting Syndrome. J Pediatr Gastroenterol Nutr. 2023 Sep 1;77(3):347-353. doi: 10.1097/MPG.0000000000003876. Epub 2023 Jun 26.
- Background: PubMed 36716443Kolacz J, Kovacic K, Dang L, Li BUK, Lewis GF, Porges SW. Cardiac Vagal Regulation Is Impeded in Children With Cyclic Vomiting Syndrome. Am J Gastroenterol. 2023 Jul 1;118(7):1268-1275. doi: 10.14309/ajg.0000000000002207. Epub 2023 Jan 30.
- Individual participant dataSharing planned: Yes. De-identified IPD such as patient reported outcome survey data may be shared with other researchers upon request
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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.
Gila Ginzburg, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active percutaneous electrical nerve field stimulation in people with Cyclic Vomiting Syndrome, run by Medical College of Wisconsin at 1 site in United States.
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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Unteutsch, BS (4142664844, runteutsch@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cyclic Vomiting Syndrome Burden Index (time frame: From enrollment (baseline) to 6 months after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07465614, which also lists 4 linked publications.
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 16 Mar 2026.