RecruitingNot Applicable

Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children

Pakistan68 participantsStarted 2026-03-01

Plain-language summary

This randomized controlled trial will evaluate the effectiveness of neuroplasticity-targeted supplements on neuroinflammatory markers and ADHD symptoms in children aged 6 to 12 years diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Participants will be randomly assigned to one of four groups: gut-targeted supplements (prebiotics and probiotics), brain-targeted supplements (omega-3 fatty acids and vitamin B1), combined supplementation, or placebo. The intervention period will last 12 weeks. Primary outcomes include changes in ADHD symptom severity and clinical scores using validated rating scales. Secondary outcomes include changes in biomarkers of neuroinflammation and neuroplasticity, including IL-6, TNF-alpha, BDNF, short-chain fatty acids, and Claudin-5.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * DSM-5 confirmed ADHD diagnosis * Age 6-12 years * Medication-free or on stable stimulant medication (≥1 month) Exclusion Criteria: * Antibiotic use in last 4 weeks * Gastrointestinal disorders * Neurological comorbidities (e.g., epilepsy) * Severe food allergies

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Parent and Teacher ADHD Rating

Timeframe: Baseline and Week 12

Neuroinflammation Markers (IL-6, TNF-α)

Timeframe: Baseline and Week 12

Neuroplasticity Markers (BDNF, Claudin-5)

Timeframe: Baseline and Week 12

Short-Chain Fatty Acids (SCFA)

Timeframe: Baseline and Week 12

Complete Blood Count (CBC)

Timeframe: Baseline and Week 12

ADHD Diagnostic Parent and Teacher Rating

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT07665658

SponsorKhyber Medical University Peshawar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Dr Dur E Shawar, PhD*

03348405894 shehwar88@gmail.com

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials

Plain-language summary

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Parent and Teacher ADHD Rating

Timeframe: Baseline and Week 12

Neuroinflammation Markers (IL-6, TNF-α)

Timeframe: Baseline and Week 12

Neuroplasticity Markers (BDNF, Claudin-5)

Timeframe: Baseline and Week 12

Short-Chain Fatty Acids (SCFA)

Timeframe: Baseline and Week 12

Complete Blood Count (CBC)

Timeframe: Baseline and Week 12

ADHD Diagnostic Parent and Teacher Rating

Timeframe: Baseline and Week 12