Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898438
Status:
RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-04-10
Brief Title:
The Role of Gut Microbiota in Children With Epilepsy Following Ketogenic Diet
Sponsor:
Attikon Hospital
Organization:
Attikon Hospital
Study Overview
Official Title:
The Role of Gut Microbiota in Children With Epilepsy Following Ketogenic Diet
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The high-fat adequate protein low-carbohydrate ketogenic diet KD has successfully been used in the treatment of drug resistant epilepsy DRE in children since 1920s The classical KD with fat to carbohydrate plus protein ratio of 3 or 41 as well as less restrictive forms such as Modified Atkins Diet MAD or Low Glycemic Index Therapy LGIT have been proved to be effective in reducing seizures more than 50 in many patients with low response to more than two antiepileptic drugs AEDs Apart from a great number of epileptic syndromes metabolic conditions like GLUT I-Glucose Transporter I - Deficiency Syndrome and Pyruvate Dehydrogenase Deficiency Syndrome seem to be especially responsive to KD
The role of human microbiota in neurological disorders via the microbiota-gut-brain axis with gut microorganisms getting involved in multiple gut and brain functions and metabolic pathways has recently gained attention The changes of gut microbiota by the low carbohydrate and low fibre ketogenic diet seem to have an impact on its effectiveness in epilepsy control Furthermore metabolic products of gut microorganisms such as SCFAs apart from producing energy are implicated in inflammatory pathways and are directly affected by the low fibre - carbohydrate content of the ketogenic diet
The small number of studies so far confirm the role of gut microbiome in seizure control without specifying the exact mechanisms yet The aim of the present study is to further investigate how gut microbiota and the metabolic products of microorganisms are implicated in the effectiveness of ketogenic diet therapy in epileptic children
The study will include epileptic children 2-18 years old eligible for ketogenic diet according to ILAE The gut microbiome of participants will be examined at the beginning of the study and three months after following an olive-oil based ketogenic diet therapy One of the participants parents will also be included providing fecal samples for the examination of gut microbiome A written informed consent will be provided by all the participants or care givers
This is a prospective non-interventional study which will be held in the Department of Pediatric Neurology 3d Pediatric Clinic Attikon Athens University Hospital in collaboration with the Department of Nutrition and Dietetics Harokopio University The study has received approval by the Ethics Committee and the Scientific Board of the Attikon Athens University Hospital
The role of human microbiota in neurological disorders via the microbiota-gut-brain axis with gut microorganisms getting involved in multiple gut and brain functions and metabolic pathways has recently gained attention The changes of gut microbiota by the low carbohydrate and low fibre ketogenic diet seem to have an impact on its effectiveness in epilepsy control Furthermore metabolic products of gut microorganisms such as SCFAs apart from producing energy are implicated in inflammatory pathways and are directly affected by the low fibre - carbohydrate content of the ketogenic diet
The small number of studies so far confirm the role of gut microbiome in seizure control without specifying the exact mechanisms yet The aim of the present study is to further investigate how gut microbiota and the metabolic products of microorganisms are implicated in the effectiveness of ketogenic diet therapy in epileptic children
The study will include epileptic children 2-18 years old eligible for ketogenic diet according to ILAE The gut microbiome of participants will be examined at the beginning of the study and three months after following an olive-oil based ketogenic diet therapy One of the participants parents will also be included providing fecal samples for the examination of gut microbiome A written informed consent will be provided by all the participants or care givers
This is a prospective non-interventional study which will be held in the Department of Pediatric Neurology 3d Pediatric Clinic Attikon Athens University Hospital in collaboration with the Department of Nutrition and Dietetics Harokopio University The study has received approval by the Ethics Committee and the Scientific Board of the Attikon Athens University Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None