Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance (KEOPS)

This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and children up to 17 years of age (i.e. 18 years minus 1 day) with drug-resistant epilepsy.

This study is being conducted according to standard medical practice. No change in diagnostic or therapeutic management habits is imposed by this study. Quality of life questionnaires are the only additional procedures for this research.

Study Overview

• Status: Recruiting
• Conditions: Drug Resistant Epilepsy; Ketogenic Dieting
• Intervention / Treatment: Other: Ketocal

Detailed Description

NUTRICIA has developed the KetoCal® range (4:1 and 3:1), a food for special medical purposes (DADFMS), to help healthcare professionals and patients establish and maintain a CR. KetoCal® 4:1 features a 4:1 ratio of fat to (carbohydrate + protein), while containing vitamins, minerals, trace elements and fiber. Similarly, KetoCal® 3:1 has a 3:1 ratio of lipids / (carbohydrates + proteins), while containing vitamins, minerals, trace elements and fiber. The KetoCal® range can be consumed orally, as a drink after dilution in hot water, incorporated as an ingredient in a recipe or administered by enteral feeding tube.

The KEOPS study is designed to gather real-life data on the therapeutic value of using the KetoCal® range in the management of drug-resistant epilepsy in infants (from 5 months) and children up to 18 years of age. Patients will be managed according to standard care practices. Initiation of ketogenic dieting will be at the investigator's discretion during the child's hospitalization.

• Study Type: Observational
• Enrollment (Estimated): 133

Contacts and Locations

• Study Contact: Name: Elmire DEGOUL-COMBESCOT, PhD; Phone Number: +33 (0) 6 27 91 97 08; Email: Elmire.DEGOUL@danone.com

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • CHRU Lille
    • Contact: Adeline TRAUFFLER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 133 eligible patients will be recruited in this project. The target population of our project will be infants (from 5 months of age) and children up to 18 years of age treated for drug-resistant epilepsy, who, depending on the physician in charge of the patient, may benefit from the initiation of a KetoCal® 3:1 or 4:1 CR, depending on the child's age.

We exclude from our study protected legal representatives of minors (under guardianship, curatorship, minor parents). In addition, people taking part in this study will not be able to take part in any other interventional or observational research for the duration of the study. A 6-month exclusion period is planned as part of this project.

Description

Inclusion Criteria:

• Infants from 5 months and children up to 17 years of age (maximum 18 years minus 1 day).
• With drug-resistant epilepsy according to ILAE (International League Against Epilepsy) criteria: persistence of epileptic seizures after failure of two appropriate antiepileptic drugs tried consecutively or in well-tolerated combination.
• Indication for CR by a physician.
• Parents (or legal guardians) able to set up and follow the diet, assessed during a joint doctor-dietician consultation.
• Written authorization from one (or both) parents or the child's legal representative to collect personal information about their child.
• Affiliation of the infant/child with the social security system.

Exclusion Criteria:

• Contraindication to ketogenic diet at initial assessment.
• Children already on a ketogenic diet.
• Parenteral nutrition.
• Concurrent prescription of other foodstuffs intended for special medical purposes (DADFMS) such as KetoVie or Keyo.
• Protected legal representative (under legal protection, or deprived of liberty by judicial or administrative decision).
• Legal representative not covered by a social security scheme.
• Legal representative unable to understand study protocol.

Ancillary study eligibility criteria :

• Patients included in the study.
• Continued on the ketogenic diet for at least 2 months.
• Having consented to participate in the ancillary study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Infants (from 5 months) and children up to 17 years of age follow up for drug resistant epilepsy	Other: Ketocal; ketogene diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of compliance	Retention rate which is defined as the proportion of patients who have continued KD for up to 6 months.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of compliance	Describe the duration of KD compliance.	From Month 1 to Month 6
Efficacy of KD	Describe the efficacy of KD. Efficacy is defined as responders to KD with seizure frequency reduced by more than 50%, or no seizure frequency in the case of total response to CR in the last week.	From Month 1 to Month 6
KD tolerance.	Describe KD tolerance as a number of AE reported	From inclusion to Month 6
QoL evolution	Describe changes in patients' quality of life following initiation of KD at inclusion, and M6; using PedsQL ™ questionnaires	From inclusion to Month 6
Influence of KD	Total number of antiepileptic drugs used for each child including their current treatment until the end of the study.	From inclusion to Month 6
Ketosis achievement	Evaluate the time it takes to achieve ketosis. Ketosis will be assessed by ketonuria or ketonemia, depending on the habits of each center.	From inclusion to Month 6

Collaborators and Investigators

• Sponsor: Nutricia Nutrition Clinique
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: epilepsy; ketogenic diet; drug resistance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 2023-A01073-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No