Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children
22 giugno 2026 aggiornato da: Khyber Medical University Peshawar
Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children: A Randomized Controlled Trial
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.
Panoramica dello studio
Stato
Reclutamento
Descrizione dettagliata
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. Emerging evidence suggests that neuroinflammation, altered gut microbiota, and impaired neuroplasticity may contribute to ADHD pathophysiology. Nutritional interventions that target these mechanisms may provide additional therapeutic benefit.
This study is a randomized, placebo-controlled, parallel-group clinical trial designed to investigate whether supplementation with prebiotics, probiotics, omega-3 fatty acids, and vitamin B1 can improve ADHD symptoms and related biological markers in children. Sixty-eight participants aged 6 to 12 years with DSM-5 confirmed ADHD will be enrolled and randomly assigned in equal numbers to one of four intervention groups: (1) prebiotics plus probiotics, (2) omega-3 fatty acids plus vitamin B1, (3) combined supplementation, or (4) placebo.
The intervention duration will be 12 weeks. ADHD symptoms and behavioral scores will be assessed at baseline and after treatment using validated rating scales, including Conners 3 and Vanderbilt ADHD forms. Blood samples will be collected at baseline and week 12 for measurement of inflammatory and neuroplasticity biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), brain-derived neurotrophic factor (BDNF), short-chain fatty acids (SCFA), Claudin-5, and complete blood count parameters.
The primary objective is to determine the effect of supplementation on ADHD symptom scores. Secondary objectives include comparison of treatment groups for biomarker changes and evaluation of associations between biological markers and clinical outcomes. Results may help identify safe adjunctive nutritional strategies for children with ADHD.
Tipo di studio
Interventistico
Iscrizione (Stimato)
68
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Dr Dur E Shawar, PhD*
- Numero di telefono: 03348405894
- Email: shehwar88@gmail.com
Backup dei contatti dello studio
- Nome: Prof Dr Inayat Shah, PhD
- Numero di telefono: 03321431414
- Email: inayat.shah@kmu.edu.pk
Luoghi di studio
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KPK
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Peshawar, KPK, Pakistan, 25000
- Reclutamento
- Khyber Teaching Hospital
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Contatto:
- Dr Dur e
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Contatto:
- Dr Inayat Khan
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Gut-Targeted Supplements Group
Participants will receive prebiotics (inulin 6 g/day) and probiotics (Acidophilus Bifidus 2 × 10^11 CFU/day orally) for 12 weeks.
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Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
Altri nomi:
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Altri nomi:
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Sperimentale: Neuroplasticity-Targeted Supplements Group
Participants will receive omega-3 fatty acids containing EPA 650 mg and DHA 540 mg daily, plus vitamin B1 (thiamine 10 mg/day orally) for 12 weeks.
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Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
Altri nomi:
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Altri nomi:
|
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Sperimentale: Combined Supplements Group
Participants will receive prebiotics (inulin 6 g/day), probiotics (Acidophilus Bifidus 2 × 10^11 CFU/day), omega-3 fatty acids containing EPA 650 mg and DHA 540 mg daily, and vitamin B1 (thiamine 10 mg/day orally) for 12 weeks.
|
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
Altri nomi:
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Altri nomi:
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
Altri nomi:
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Altri nomi:
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Comparatore placebo: Placebo Group
Participants will receive matching placebo supplements orally for 12 weeks.
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Participants will receive matching placebo supplementation orally once daily for 12 weeks.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Parent and Teacher ADHD Rating
Lasso di tempo: Baseline and Week 12
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Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptom severity measured using the Conners 3 Parent and Teacher ADHD Rating Scales. The Conners 3 assesses inattention, hyperactivity/impulsivity, executive functioning, learning problems, aggression, and peer relations. Raw scores are converted to T-scores, with higher scores indicating greater symptom severity and functional impairment. Scale Information: T-score range: approximately 40-90 Higher scores indicate worse ADHD symptoms. |
Baseline and Week 12
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Neuroinflammation Markers (IL-6, TNF-α)
Lasso di tempo: Baseline and Week 12
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Change in serum levels of pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-alpha measured by ELISA
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Baseline and Week 12
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Neuroplasticity Markers (BDNF, Claudin-5)
Lasso di tempo: Baseline and Week 12
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Change in brain-derived neurotrophic factor (BDNF) and blood-brain barrier tight junction protein claudin-5 measured by ELISA
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Baseline and Week 12
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Short-Chain Fatty Acids (SCFA)
Lasso di tempo: Baseline and Week 12
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Change in gut microbiota-derived metabolites (e.g., butyrate) measured by ELISA
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Baseline and Week 12
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Complete Blood Count (CBC)
Lasso di tempo: Baseline and Week 12
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Change in blood cell counts (e.g., white blood cells, red blood cells, platelets)
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Baseline and Week 12
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ADHD Diagnostic Parent and Teacher Rating
Lasso di tempo: Baseline and Week 12
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Change in ADHD symptom severity measured using the Vanderbilt ADHD Diagnostic Parent and Teacher Rating Scales. The symptom assessment includes 18 ADHD items corresponding to DSM criteria for inattentive and hyperactive-impulsive symptoms. Total symptom scores range from 0 to 54, with higher scores indicating greater ADHD symptom severity. Scale Information: Minimum score: 0 Maximum score: 54 Higher scores indicate worse ADHD symptoms. |
Baseline and Week 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Dr Dur E Shawar, PhD*, Khyber Medical University Peshawar, Pakistan
- Investigatore principale: Prof Dr Inayat Shah, PhD, Khyber Medical University Peshawar, Pakistan
- Investigatore principale: Prof Dr Omer Malik, PhD, Khyber Medical University Peshawar, Pakistan
- Investigatore principale: Dr Madiha Khattak, PhD, Khyber Medical College
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Allahyari P, Abbas Torki S, Aminnezhad Kavkani B, Mahmoudi Z, Mousavi Hoseini MS, Moradi M, Alami F, Keshavarz Mohammadian M, Bahoo Sele Bani S, Abbasi Mobarakeh K, Shafaei H, Khoshdooz S, Hajipour A, Doaei S, Gholamalizadeh M. A systematic review of the beneficial effects of prebiotics, probiotics, and synbiotics on ADHD. Neuropsychopharmacol Rep. 2024 Jun;44(2):300-307. doi: 10.1002/npr2.12437. Epub 2024 Apr 16.
- Levy Schwartz M, Magzal F, Yehuda I, Tamir S. Exploring the impact of probiotics on adult ADHD management through a double-blind RCT. Sci Rep. 2024 Nov 5;14(1):26830. doi: 10.1038/s41598-024-73874-y.
- Yin X, Liu W, Feng H, Huang J, Wang Q, Zhang Q, He J, Wang R. Bifidobacterium animalis subsp. lactis A6 attenuates hippocampal damage and memory impairments in an ADHD rat model. Food Funct. 2024 Mar 4;15(5):2668-2678. doi: 10.1039/d3fo04665f.
- Checa-Ros A, Jerez-Calero A, Molina-Carballo A, Campoy C, Munoz-Hoyos A. Current Evidence on the Role of the Gut Microbiome in ADHD Pathophysiology and Therapeutic Implications. Nutrients. 2021 Jan 16;13(1):249. doi: 10.3390/nu13010249.
- Sayed SZ, Hassan ZO, Abdelraheem WM, Refaat RS, Abuelela IS. Is there a link between peripheral inflammation and blood brain barrier integrity in children with attention-deficit/hyperactivity disorder? A case-control study. BMC Pediatr. 2024 Nov 26;24(1):769. doi: 10.1186/s12887-024-05254-4.
- Steckler R, Magzal F, Kokot M, Walkowiak J, Tamir S. Disrupted gut harmony in attention-deficit/hyperactivity disorder: Dysbiosis and decreased short-chain fatty acids. Brain Behav Immun Health. 2024 Jul 27;40:100829. doi: 10.1016/j.bbih.2024.100829. eCollection 2024 Oct.
- Young GS, Conquer JA, Thomas R. Effect of randomized supplementation with high dose olive, flax or fish oil on serum phospholipid fatty acid levels in adults with attention deficit hyperactivity disorder. Reprod Nutr Dev. 2005 Sep-Oct;45(5):549-58. doi: 10.1051/rnd:2005045.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 marzo 2026
Completamento primario (Stimato)
30 novembre 2026
Completamento dello studio (Stimato)
25 dicembre 2026
Date di iscrizione allo studio
Primo inviato
16 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 giugno 2026
Primo Inserito (Effettivo)
24 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Disordini mentali
- Processi patologici
- Infiammazione
- Disturbi del neurosviluppo
- Disturbi da deficit di attenzione e comportamento dirompente
- Condizioni patologiche, segni e sintomi
- Malattie neuroinfiammatorie
- Disturbo da deficit di attenzione con iperattività
- Composti di zolfo
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Acidi grassi
- Lipidi
- Tiazoli
- Azoli
- Integratori dietetici
- Cibo
- Dieta, cibo e nutrizione
- Fenomeni fisiologici
- Cibo e bevande
- Carboidrati dietetici
- Carboidrati
- Pirimidine
- Polimeri
- Sostanze macromolecolari
- Polisaccaridi
- Amido
- Glucani
- Acidi grassi, insaturi
- Biopolimeri
- Fruttani
- Oli
- Grassi dietetici
- Grassi
- Grassi dietetici, insaturi
- Tiamina
- Probiotici
- Inulina
- Oli di pesce
- Acidi grassi, Omega-3
Altri numeri di identificazione dello studio
- KMU/DIR/CTU/2026/02
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
IPD that underlie the results reported in publications, including demographic data, baseline characteristics, ADHD symptom scores, laboratory measurements, and intervention allocation data, will be shared after de-identification.
Data will be provided in a manner that protects participant confidentiality and privacy.
Supporting study documents including the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code will also be made available.
IPD that underlie the results reported in publications, including demographic data, baseline characteristics, ADHD symptom scores, laboratory measures, and intervention allocation data, will be shared after de-identification.
Data will be provided in a manner that protects participant confidentiality and privacy.
Supporting study documents including the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code will also be made available.
Periodo di condivisione IPD
Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
Criteri di accesso alla condivisione IPD
De-identified participant data and supporting documents will be made available to qualified researchers who provide a methodologically sound research proposal.
Requests should be directed to the Principal Investigator.
Access will be granted following review and approval of the proposal and execution of a data-sharing agreement that ensures participant confidentiality and compliance with applicable ethical and regulatory requirements.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .