Exogenous Ketone Esters for Drug Resistant Epilepsy

Launched by SOHAG UNIVERSITY · Dec 31, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring whether exogenous ketone esters, which are supplements that can help the body produce energy without relying on carbohydrates, can help children with drug-resistant epilepsy, a condition where seizures don’t respond well to traditional medications. The study is currently looking for participants, specifically children aged 1 to 16 years who have been experiencing at least 7 seizures a week and have not found success with their current treatments.

If you consider participating, it’s important to know that certain health conditions may prevent eligibility, such as serious liver or kidney problems, recent dietary changes, or issues related to blood sugar levels. Participants will be closely monitored throughout the trial, and the goal is to see if adding these ketone supplements can reduce seizure frequency and improve overall quality of life. If you have any questions or think your child might be a good fit, discussing it with your healthcare provider could be a great next step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Drug-resistant epilepsy
• • Seizure frequency ≥ 7 per week
• Exclusion Criteria:
• • Failure to obtain informed consent
• • Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications
• • Severe disease conditions, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems
• • Hypo-/hyperglycemia
• • Metabolic acidosis
• • Ketosis (βHB \> 2 mmol/L)
• • GIT disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel disease
• • Malnutrition/obesity
• • Limitations to oral feeding (e.g., severe gastroesophageal reflux)
• • Inborn errors of metabolism
• • Chromosomal disorders
• • Surgically-remediable epilepsy
• • Allergies or any other contraindication to ketone supplements
• • Inapplicable recording of seizures
• • Incompliance to anti-seizure medications and/or irregular follow-up
• • Recent propofol therapy
• • Intake of carbonic-anhydrase inhibitors