Actively Recruiting

Phase 2
Phase 3
Age: 1Year - 16Years
All Genders
NCT05670847

Exogenous Ketone Esters for Drug Resistant Epilepsy

Led by Sohag University · Updated on 2024-11-27

60

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy

CONDITIONS

Official Title

Exogenous Ketone Esters for Drug Resistant Epilepsy

Who Can Participate

Age: 1Year - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Drug-resistant epilepsy
  • Seizure frequency �3E= 7 per week
Not Eligible

You will not qualify if you...

  • 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 (b2HB > 2 mmol/L)
  • Gastrointestinal tract disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel disease
  • Malnutrition or obesity
  • Limitations to oral feeding such as severe gastroesophageal reflux
  • Inborn errors of metabolism
  • Chromosomal disorders
  • Surgically-remediable epilepsy
  • Allergies or any 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Pediatrics at Sohag University Hospital

Sohag, Egypt, 82524

Actively Recruiting

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Research Team

E

Elsayed M Abdelkreem, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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