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Could a High-Fat diet tame Super-Refractory seizures?

NCT ID NCT07496749

Disease control Sponsor: Xuanwu Hospital, Beijing Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a ketogenic diet (a high-fat, low-carbohydrate diet) can help stop super-refractory status epilepticus—a life-threatening condition where seizures continue despite standard medications. The diet is given via feeding tube or by mouth to 84 ICU patients aged 14–80. Researchers will measure how quickly seizures stop using brain wave monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketogenic diet (a high-fat, low-carbohydrate diet given via feeding tube or by mouth)
What this could lead to
If it works, this could offer a new, drug-free option to stop prolonged seizures in the ICU, potentially reducing brain damage and time on life support.
What could go wrong
This is a relatively small trial (84 people) and the diet can cause side effects like digestive issues or nutrient imbalances. It may not work for everyone, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients diagnosed with super-refractory status epilepticus (SRSE), in whom status epilepticus (SE) persists or recurs after the initial treatment for SE-including intravenous benzodiazepines, an anti-seizure medication (ASM, such as valproate, levetiracetam, or phenobarbital), and an anesthetic (e.g., propofol) administered continuously for 24 hours-fails to terminate the episode, or when SE recurs upon reduction of the anesthetic. * Age between 14 and 80 years, regardless of gender. * The patient's legal guardian has provided signed informed consent. Exclusion Criteria: * Patients with lipid metabolism disorders, including defects in fatty acid transport and beta-oxidation, such as carnitine deficiency (primary) and carnitine-related enzyme deficiencies (including carnitine palmitoyltransferase \[CPT\] I and II deficiency, carnitine translocase deficiency), fatty acid oxidation disorders (including beta-oxidation defects), short-chain acyl-CoA dehydrogenase deficiency (SCAD), medium-chain acyl-CoA dehydrogenase deficiency (MCAD), long-chain acyl-CoA dehydrogenase deficiency (LCAD), long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, medium-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, pyruvate carboxylase deficiency, and porphyria. * Intolerance to enteral feeding (e.g., intestinal obstruction). * Receipt of propofol infusion within 24 hours. * Hemodynamic instability (systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg, requiring high-dose vasopressors for maintenance). * Liver failure (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], blood ammonia \>5 times the upper limit of normal; total bilirubin \>10 mg/dL \[171 μmol/L\]). * Pancreatitis. * Pregnancy. * Metabolic instability (blood glucose \<3.1 mmol/L, arterial blood pH \<7.2, serum sodium \<120 or \>160 mmol/L). * Septic shock. * Complicated by diabetes insipidus. * Status epilepticus caused by hypoxic-ischemic brain injury.

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Conditions

The condition(s) this trial relates to.

encephalitis Status Epilepticus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Super-refractory status epilepticus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tongren Hospital, Capital Medical University

    NOT_YET_RECRUITING

    Beijing, 100730, China

  • Chifeng Municipal Hospital

    RECRUITING

    Chifeng, Neimenggu, 024000, China

  • Department of Neurology, Xuanwu Hospital Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, Guizhou, 550002, China

  • Liaocheng People's Hospital

    RECRUITING

    Liaocheng, 252000, China

  • Qilu Hospital，Shandong University

    NOT_YET_RECRUITING

    Jinan, Shandong, 2500012, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150001, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050031, China

  • The First Hospital of Jilin University

    RECRUITING

    Jilin City, 130021, China

  • The Second Affiliated Hospital of Hainan Medical University

    NOT_YET_RECRUITING

    Haikou, Hainan, 570311, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hanzhou, Zhejiang, 310009, China

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