Outcomes of Drug Resistant Epileptic Pediatric Patient by... | NCT07275125

Studies
Outcomes of Drug Resistant Epileptic Pediatric Patient by Modified Atkins Diet

NCT07275125

Sponsor

Sohag University

Status

Not yet recruiting

Last Update Posted

Dec 10, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Drug Resistant Epilepsy

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2025Estimated

Primary Completion Date

May 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Sep 28, 2025

First Submission Date that Met QC Criteria

Nov 28, 2025

First Posted Date

Dec 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2025

Last Update Posted Date

Dec 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess clinical outcomes in drug resistant epileptic pediatric patient by modified atkin diet with focusing on following points:

Control of seizures(frequency , duration and numbers of hospital admissions) .
Quality of life by pediatric quality of life inventory v4.
Cognitive function by stanford binet intelligence scale 5th edition.
Growth parameters ( weight, height will be combined to report BMI in kg/m^2).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1-Control of seizures(frequency and duration of seizures) . 2-Quality of life by pediatric quality of life inventory v4. 3-Cognitive function by stanford binet intelligence scale 5th edition. 4-Growth parameters (weight and height by BMI in kg/m^2)		6 month

Secondary Outcomes

Measure	Description	Time Frame
to detect clinical predictors of seizures control ( frequency of attack and duration) in patients with drug resistant epilepsy using MAD.		6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 1-18 years.
Diagnosed with drug-resistant epilepsy according to ILAE definition.[2]
On KD for at least 6 months.

Exclusion Criteria:

- Patients with contraindicated metabolic/genetic conditions.
Non-compliance with KD .

Patients on alternative dietary therapies (e.g., low glycemic diet)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

This study will include pediatric patients with drug-resistant epilepsy (DRE) attending the ketogenic diet clinic at the Pediatric Neurology Unit, Sohag University Hospital. Eligible participants are children aged 1-18 years who meet the International League Against Epilepsy (ILAE) definition of DRE and have been on a ketogenic dietary therapy, specifically the Modified Atkins Diet (MAD), for at least 6 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Saber Elsayed	Contact	00201069770585		Mm.ss.elsayed277@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag faculty of medicine		Sohag			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000069279	Drug Resistant Epilepsy

Ancestor Terms

ID	Term
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided