Attention Deficit DisorderNCT06491836
Oligoantigenic Diet and Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).
A study testing oligoantigenic diet and Food regimen without food restrictions. in people with Attention Deficit Disorder, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Attention Deficit Disorder
- What is being tested?
- oligoantigenic diet and Food regimen without food restrictions.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Presence of other medical conditions as chronic medical illness or other neuropsychiatric disorders
- Intelligence quotient (IQ) of patients less than 80%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an Oligoantigenic Diet on 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.
- Conditions
- Attention Deficit Disorder
- Being tested
- oligoantigenic diet, Food regimen without food restrictions.
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oligoantigenic dietDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Patients who will follow food regimen without any food restriction. | Active comparator | Not described Receives: Other: Food regimen without food restrictions. |
| Arm 2: Patients who will follow food regimen based on oligoantigenic diet. | Experimental | Not described Receives: Dietary Supplement: oligoantigenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Sep 2024
- Primary completion1 Oct 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haya Essam Ibrahim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491836
- Sponsor's protocol ID
- FMASU MS157/2024
- Status last verified
- Dec 2025
- First submitted
- 28 Jun 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Oligoantigenic Diet on Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).
- ClinicalTrials.gov ID
- NCT06491836
- Acronym / sponsor ID
- FMASU MS157/2024
- Conditions
- Attention Deficit Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of other medical conditions as chronic medical illness or other neuropsychiatric disorders
- Intelligence quotient (IQ) of patients less than 80%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oligoantigenic dietOligoantigenic 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) | Dietary supplement | Arm 2: Patients who will follow food regimen based on oligoantigenic diet. |
| Food regimen without food restrictions.Food regimen that will cover recommended daily allowance (RDA) for macronutrients and micronutrients according patients' ages without any food restriction | Other | Arm 1: Patients who will follow food regimen without any food restriction. |
Primary outcome
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oligoantigenic diet and Food regimen without food restrictions. in people with Attention Deficit Disorder, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conner's Parent Rating Scales-Revised (CRS-R) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.