Effect of supplementing ketogenic diet in the treatment of refractory epilepsy in children and its influence on gut microbiota

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035141

Enrollment

Unknown

Registered

2020-08-01

Start date

2020-08-17

Completion date

Unknown

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory epilepsy

Interventions

Experimental group:ketogenic diet

control group:antiepileptic drug

Eligibility

Sex/Gender

All

Age

2 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of refractory epilepsy (ilae2010); 2. Patients without ketogenic diet in the past; 3. Patients aged 2-10 years: 4. Patients with seizure frequency > 4 times per month; 5. Parents agree to add ketogenic diet treatment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with fatty metabolic liver disease and other metabolic diseases; 2. Patients with fever or infectious disease; 3. Contraindications of ketogenic diet: Diseases interfering with glucose and fat metabolism, or liver metabolic diseases (diabetes, carnitine deficiency, mitochondrial enzyme deficiency, ketotic hypoglycemia, etc.); 4. Excluding patients with serious diseases such as digestive system, cardiovascular system, respiratory system, urinary system and immune deficiency; 5. Patients who took antibiotics and hormone drugs within 3 months before enrollment.

Design outcomes

Primary

Measure	Time frame
Seizure frequency;Composition of gut microbiota;	—

Secondary

Measure	Time frame
Electroencephalogram;	—

Countries

China

Contacts

Public ContactLi Hua

Guangdong Sanjiu Brain Hospital

lihua1051@163.com+86 13631446331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026