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Completed

NCT Number: NCT06491836

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

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.

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Key information

Conditions

Attention Deficit Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbassia, 1181, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

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)

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

Primary outcomes

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

    Time frame: 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.

  2. Child Behavior Checklist (CBCL/6-18)

    Time frame: 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.

  3. The Continuous Performance Test (CPT)

    Time frame: 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.

  4. Clinical Global Impression

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of an Oligoantigenic Diet on Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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