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

NCT06491836 | Completed

• 1 other identifier: FMASU MS157/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder

Outcome Measures

Primary Outcomes (4)

• Conner's Parent Rating Scales-Revised (CRS-R)

  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.

  3 months

• Child Behavior Checklist (CBCL/6-18)

  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.

  3 months

• The Continuous Performance Test (CPT)

  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.

  3 months

• Clinical Global Impression

  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

  3 months

Study Arms (2)

Arm 1: Patients who will follow food regimen without any food restriction.

ACTIVE COMPARATOR

Other: Food regimen without food restrictions.

Arm 2: Patients who will follow food regimen based on oligoantigenic diet.

EXPERIMENTAL

Dietary Supplement: oligoantigenic diet

Interventions

oligoantigenic diet DIETARY_SUPPLEMENT

Oligoantigenic diet that will cover recommended daily allowance (RDA) of macronutrients and micronutrients according patients' ages according to our available sources of food in our culture and the diet consists typically of meat (e.g. chicken and lamb), carbohydrate sources (e.g., potatoes and rice), fruits (e.g., bananas, pears and apples), vegetables (e.g., cucumbers, carrot, lettuce, cauliflower, turnips, cabbage and broccoli)

Arm 2: Patients who will follow food regimen based on oligoantigenic diet.

Food regimen without food restrictions. OTHER

Food regimen that will cover recommended daily allowance (RDA) for macronutrients and micronutrients according patients' ages without any food restriction

Arm 1: Patients who will follow food regimen without any food restriction.

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 1181, Egypt

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 9, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 15, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

EG (1)