The Role of Gut Microbiota in Children With Epilepsy Following Ketogenic Diet

NCT05898438 | Unknown

• 1 other identifier: ΕΒΔ620/30-09-2019
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The role of human microbiota in neurological disorders via the "microbiota-gut-brain axis" is recently gaining increased attention due to the knowledge that gut microorganisms are involved in multiple gut and brain functions and metabolic pathways. The hypothesis of the present investigation is that changes of gut microbiota and their metabolic products may be a mechanism of the effectiveness of ketogenic diet in epilepsy. The aim of the present study is to investigate the changes of gut microbiota induced by the ketogenic diet and if certain populations of microorganisms are associated with better seizure control in epileptic children. This is a non-interventional study that will include epileptic children 2-18 years old eligible for ketogenic diet. The gut microbiome of participants will be examined in stools before and three months after the implementation of an olive oil- based ketogenic diet therapy. One of the participants' parents will also be included providing fecal sample for the examination of gut microbiome.

Conditions

Epilepsy

Keywords

ketogenic diet; epilepsy; children; gut microbiota

Outcome Measures

Primary Outcomes (2)

• Change of epileptic seizures frequency

  Recording of number of seizures per week/month Recording the ratio of epileptic seizures change e.g. decrease \>50%, decrease 50-90%, decrease \>90%

  3 months

• Changes in electroengephalographic activity

  Subjective assessment of neurophysiologist depending on the diagnosis of each patient's epileptic syndrome. Measurement of Spike Wave Index (%) in Electrical Status Epilepticus During Slow-wave Sleep (ESES)

  3 months

Secondary Outcomes (2)

• Alterations in gut microbiota

  3 months

• Changes in gut microbial metabolites

  3 months

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with epilepsy visiting Pediatric Neurology Department of 3rd Pediatric Clinic, Attikon Athens University Hospital

You may qualify if:

• type of epilepsy requiring ketogenic diet (drug-resistant epilepsy or Glut 1 DS or PDHD)
• eligibility for ketogenic diet according to ILAE
• no antibiotic intake for at least 2 months before the beginning of the study
• no probiotics or prebiotics intake for at least 2 weeks before the beginning of the study

You may not qualify if:

• \- systematic diseases (e.g. inflammatory bowel disease, cancer, autoimmune and cardiometabolic diseases)

Sponsors & Collaborators

• Attikon Hospital: lead
• Harokopio University: collaborator

Study Sites (1)

Attikon Athens University Hospital

Athens, Haidari, 12462, Greece

RECRUITING

Related Publications (7)

• Olson CA, Vuong HE, Yano JM, Liang QY, Nusbaum DJ, Hsiao EY. The Gut Microbiota Mediates the Anti-Seizure Effects of the Ketogenic Diet. Cell. 2018 Jun 14;173(7):1728-1741.e13. doi: 10.1016/j.cell.2018.04.027. Epub 2018 May 24.

  PMID: 29804833 BACKGROUND

• Xie G, Zhou Q, Qiu CZ, Dai WK, Wang HP, Li YH, Liao JX, Lu XG, Lin SF, Ye JH, Ma ZY, Wang WJ. Ketogenic diet poses a significant effect on imbalanced gut microbiota in infants with refractory epilepsy. World J Gastroenterol. 2017 Sep 7;23(33):6164-6171. doi: 10.3748/wjg.v23.i33.6164.

  PMID: 28970732 BACKGROUND

• Zhang Y, Zhou S, Zhou Y, Yu L, Zhang L, Wang Y. Altered gut microbiome composition in children with refractory epilepsy after ketogenic diet. Epilepsy Res. 2018 Sep;145:163-168. doi: 10.1016/j.eplepsyres.2018.06.015. Epub 2018 Jun 28.

  PMID: 30007242 BACKGROUND

• Lindefeldt M, Eng A, Darban H, Bjerkner A, Zetterstrom CK, Allander T, Andersson B, Borenstein E, Dahlin M, Prast-Nielsen S. The ketogenic diet influences taxonomic and functional composition of the gut microbiota in children with severe epilepsy. NPJ Biofilms Microbiomes. 2019 Jan 23;5(1):5. doi: 10.1038/s41522-018-0073-2. eCollection 2019.

  PMID: 30701077 BACKGROUND

• Tagliabue A, Ferraris C, Uggeri F, Trentani C, Bertoli S, de Giorgis V, Veggiotti P, Elli M. Short-term impact of a classical ketogenic diet on gut microbiota in GLUT1 Deficiency Syndrome: A 3-month prospective observational study. Clin Nutr ESPEN. 2017 Feb;17:33-37. doi: 10.1016/j.clnesp.2016.11.003. Epub 2016 Dec 18.

  PMID: 28361745 BACKGROUND

• Gong X, Cai Q, Liu X, An D, Zhou D, Luo R, Peng R, Hong Z. Gut flora and metabolism are altered in epilepsy and partially restored after ketogenic diets. Microb Pathog. 2021 Jun;155:104899. doi: 10.1016/j.micpath.2021.104899. Epub 2021 Apr 21.

  PMID: 33894293 BACKGROUND

• Peng A, Qiu X, Lai W, Li W, Zhang L, Zhu X, He S, Duan J, Chen L. Altered composition of the gut microbiome in patients with drug-resistant epilepsy. Epilepsy Res. 2018 Nov;147:102-107. doi: 10.1016/j.eplepsyres.2018.09.013. Epub 2018 Sep 24.

  PMID: 30291996 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal samples

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Argirios Dinopoulos, Professor

  3rd Pediatric Clinic, Attikon Athens University Hospital

  STUDY CHAIR

Central Study Contacts

Sofia D Zouganeli

CONTACT

00306979147890; szouganeli@attikonhospital.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: June 12, 2023
• Study Start: December 18, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)