Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448663
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder CDD
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Targeting the Gut to Improve Seizure Control in CDD
Status:
RECRUITING
Status Verified Date:
2024-06
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:
NUTRIENT
Brief Summary:
Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder CDD
The study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities
The study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities
Detailed Description:
CDD is a neurodevelopmental condition characterized by infantile-onset epilepsy developmental delays intellectual and motor disabilities sleep disturbances and cortical visual impairment Currently there is no treatment for CDD and epilepsy is a prominent and severe feature of the disorder Standard anti-seizure medications have limited efficacy in seizure control leading to detrimental effects on cognitive and motor development in CDD
The gut-brain axis has gained attention in epilepsy research prompted by evidence of gastrointestinal GI symptoms in people with epilepsy Studies have demonstrated significant changes in gut microbial composition in animal models and between individuals with epilepsy and healthy subjects Notably CDD patients experience GI problems and we discovered that they exhibit alterations in their gut microbiota compared to healthy individuals The study will investigate whether supplementing CDD patients with alpha-lactalbum and prebiotics alone or with post-biotics can improve neurological features and modulate microbiota composition
The gut-brain axis has gained attention in epilepsy research prompted by evidence of gastrointestinal GI symptoms in people with epilepsy Studies have demonstrated significant changes in gut microbial composition in animal models and between individuals with epilepsy and healthy subjects Notably CDD patients experience GI problems and we discovered that they exhibit alterations in their gut microbiota compared to healthy individuals The study will investigate whether supplementing CDD patients with alpha-lactalbum and prebiotics alone or with post-biotics can improve neurological features and modulate microbiota composition
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