Epigenetics and Gut Microbiota in Children With Epilepsy

NCT04063007 | Unknown

• 1 other identifier: 2016/2016/REK sør-øst
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The ketogenic diet is a high-fat, low-carbohydrate diet used in the treatment of epilepsy. The diet can be an efficient treatment option in children with drug resistant epilepsy, with more than 50 % seizure reduction in about 40- 70 % of the patients. However, there is still a lack of knowledge regarding the mechanisms of action, how will respond to the treatment and potential adverse effects.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Characterization of the gut microbiota

  Changes in the gut microbiota composition in fecal samples from baseline to 12 weeks of dietary treatment will be measured by 16S rRNA analysis.

  From baseline to 12 weeks of dietary treatment.

• Characterization of DNA methylation

  Changes in the DNA methylation in white blood cells from baseline to 12 weeks of dietary treatment will be analyzed using the Infinium Methylation EPIC Kit.

  From baseline to 12 weeks of dietary treatment.

Secondary Outcomes (2)

• Changes in parental quality of life and parental perceptions of their child's quality of life

  12 weeks of dietary treatment.

• Adverse effects

  12 weeks of dietary treatment.

Study Arms (1)

Ketogenic diet

OTHER

The patients follow the ordinary treatment protocol for initiation and follow-up of the ketogenic diet

Other: Ketogenic diet

Interventions

Ketogenic diet OTHER

The patients follow the ordinary treatment protocol for ketogenic diet

Ketogenic diet

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Drug resistant epilepsy
• Age 2- 17 years
• Two or more countable seizures/week
• Willing to try treatment with the ketogenic diet for at least 12 weeks

You may not qualify if:

• Glucose transporter protein 1 deficiency, pyruvate dehydrogenase deficiency, or pyruvate carboxylase deficiency
• Known or suspected disease in wich the diet is contraindicated
• Epilepsy surgery the last 6 months before diet initiation
• Steroid medications the last 2 months before diet initiation
• Breastfeeding
• Psychogenic non-epileptic seizures
• Eating disorder
• Pregnancy or planed pregnancy
• Feeding disabilities not compatible with dietary treatment
• Inability to follow study scheme
• Previous treatment with high-fat, low- carbohydrate diet
• Medical need to start dietary treatment immediately

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian University of Life Sciences: collaborator
• University of Oslo: collaborator
• Lund University: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kaja K Selmer, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaja K Selmer, PhD

CONTACT

0047 22 11 77 83; k.k.selmer@medisin.uio.no

Sigrid Pedersen, MSc

CONTACT

004767501491; ketoprosjekt@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, MD, PhD

Model Details: This is a prospective, non-randomized study

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: August 20, 2019
• Study Start: August 15, 2017
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

NO (1)