Oligoantigenic Diet and Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).

Not Applicable

Not yet recruiting

• Conditions: Attention Deficit Disorder
• Interventions: Other: Food regimen without food restrictions.; Dietary Supplement: oligoantigenic diet

• Registration Number: NCT06491836
• Lead Sponsor: Ain Shams University

Brief Summary

Fifty patients who diagnosed as ADHD syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) Criteria aged from 6 to 16 years old will be assigned randomly into 2 arms: arm 1: the patients will follow food regimen that cover recommended daily allowance (RDA) for macronutrients and micronutrients suitable for their ages without any food restriction, arm 2: the patients will follow food regimen that cover (RDA) for macronutrients and micronutrients suitable for their ages based on Oligoantigenic diet (OAD). Psychiatric assessment will be done before intervention and after 3 months of intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Study Start: 2024-09-01
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Children fulfilled DSM (5) Criteria for ADHD syndrome aged from 6 to 16 years old on stable pharmacotherapy 8 weeks prior to enrollment with intention to maintain ongoing therapies constant throughout the trial.

Exclusion Criteria

• Presence of other medical conditions as chronic medical illness or other neuropsychiatric disorders
• Intelligence quotient (IQ) of patients less than 80%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Patients who will follow food regimen without any food restriction.	Food regimen without food restrictions.	-
Arm 2: Patients who will follow food regimen based on oligoantigenic diet.	oligoantigenic diet	-

Primary Outcome Measures

Name	Time	Method
Conner's Parent Rating Scales-Revised (CRS-R)	3 months	This tool is used to assess the profile and severity of symptoms, response to treatment and follow up studies. Items will be scored on 14 subscales of symptoms including opposition, cognitive problems, inattention and hyperactivity. It is usually considered normal when T-scores are less than 60, while scores above 60 are signs of academic, behavioral or social issues.
Clinical Global Impression	3 months	Scale is designed to assess the effectiveness of a particular treatment: CGI-severity scale (CGI-S) assessing illness severity and CGI-C assessing global improvement or change. CGI-S will measure illness severity at baseline and after treatment on a scale of seven points
Child Behavior Checklist (CBCL/6-18)	3 months	It is designed to obtain parents'/caregivers' reports of their children's problems and it is a reliable tool for assessing the traits associated with childhood mental health issues.
The Continuous Performance Test (CPT)	3 months	It is a measurement of sustained attention deficits. It requires participants to respond to predesignated targets among stimuli that will be presented at a rapid fixed rate.