Epilepsy Intractable Clinical Trial
Official title:
The Efficacy of Ketogenic Diet in Treating Pediatric Intractable Epilepsy and Its Relationship With Changes in Inflammatory Markers
This study aims to evaluate the efficacy of a ketogenic diet in treating pediatric intractable epilepsy and to explore its relationship with changes in inflammatory markers. The investigators plan to recruit 59 participants with intractable epilepsy, 39 of whom will receive a combination of ketogenic diet and conventional antiepileptic drugs, while 20 will receive only conventional drugs. The study will assess the impact of the ketogenic diet on epilepsy control and inflammatory markers, hoping to discover new treatment strategies.
Status | Recruiting |
Enrollment | 59 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 12 Years |
Eligibility | Inclusion Criteria: - Children aged 6 months to 12 years with a diagnosis of intractable epilepsy - more than four seizures per month - no metabolic diseases - no severe liver or kidney dysfunction. Exclusion Criteria: - Fat metabolism or other metabolic diseases - febrile or infectious periods - contraindications to the ketogenic diet - children suitable for surgery or parents refusing drug and diet intervention. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat Sen Memorial Hospital, Sun Yat Sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
Chen Z, Brodie MJ, Liew D, Kwan P. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated With Established and New Antiepileptic Drugs: A 30-Year Longitudinal Cohort Study. JAMA Neurol. 2018 Mar 1;75(3):279-286. doi: 10.1001/jamaneurol.2017.3949. Erratum In: JAMA Neurol. 2018 Mar 1;75(3):384. — View Citation
Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3. Erratum In: Epilepsia. 2010 Sep;51(9):1922. — View Citation
Loscher W, Potschka H, Sisodiya SM, Vezzani A. Drug Resistance in Epilepsy: Clinical Impact, Potential Mechanisms, and New Innovative Treatment Options. Pharmacol Rev. 2020 Jul;72(3):606-638. doi: 10.1124/pr.120.019539. — View Citation
Vezzani A, Maroso M, Balosso S, Sanchez MA, Bartfai T. IL-1 receptor/Toll-like receptor signaling in infection, inflammation, stress and neurodegeneration couples hyperexcitability and seizures. Brain Behav Immun. 2011 Oct;25(7):1281-9. doi: 10.1016/j.bbi.2011.03.018. Epub 2011 Apr 5. — View Citation
Wirrell E, Farrell K, Whiting S. The epileptic encephalopathies of infancy and childhood. Can J Neurol Sci. 2005 Nov;32(4):409-18. doi: 10.1017/s0317167100004388. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epilepsy Control Response Rate | Epilepsy control response rate: defined as an absolute reduction of =50% in seizure frequency at follow-up compared with baseline =(No attack + Marked effect + Effective)/Total number of cases × 100%. |
During the study period (16 weeks) | |
Secondary | Inflammatory Marker Levels | This indicator aims to evaluate the effect of the ketogenic diet on the levels of inflammatory markers in the blood of children with refractory epilepsy to reveal the potential relationship between the effects of the ketogenic diet and inflammation levels. | During the study period (16 weeks)] |
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