Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children
22 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
68
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Dr Dur E Shawar, PhD*
- Numéro de téléphone: 03348405894
- E-mail: shehwar88@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Prof Dr Inayat Shah, PhD
- Numéro de téléphone: 03321431414
- E-mail: inayat.shah@kmu.edu.pk
Lieux d'étude
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KPK
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Peshawar, KPK, Pakistan, 25000
- Recrutement
- Khyber Teaching Hospital
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Contact:
- Dr Dur e
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Contact:
- Dr Inayat Khan
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
Autres noms:
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Autres noms:
|
|
Expérimental: 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.
|
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
Autres noms:
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Autres noms:
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
Autres noms:
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Autres noms:
|
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Comparateur placebo: Placebo Group
Participants will receive matching placebo supplements orally for 12 weeks.
|
Participants will receive matching placebo supplementation orally once daily for 12 weeks.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Parent and Teacher ADHD Rating
Délai: Baseline and Week 12
|
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)
Délai: 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
|
Baseline and Week 12
|
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Neuroplasticity Markers (BDNF, Claudin-5)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Dr Dur E Shawar, PhD*, Khyber Medical University Peshawar, Pakistan
- Chercheur principal: Prof Dr Inayat Shah, PhD, Khyber Medical University Peshawar, Pakistan
- Chercheur principal: Prof Dr Omer Malik, PhD, Khyber Medical University Peshawar, Pakistan
- Chercheur principal: Dr Madiha Khattak, PhD, Khyber Medical College
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2026
Achèvement primaire (Estimé)
30 novembre 2026
Achèvement de l'étude (Estimé)
25 décembre 2026
Dates d'inscription aux études
Première soumission
16 juin 2026
Première soumission répondant aux critères de contrôle qualité
22 juin 2026
Première publication (Réel)
24 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Les troubles mentaux
- Processus pathologiques
- Inflammation
- Troubles neurodéveloppementaux
- Déficit de l'attention et troubles du comportement perturbateur
- Conditions pathologiques, signes et symptômes
- Maladies neuroinflammatoires
- Trouble déficitaire de l'attention avec hyperactivité
- Composés de soufre
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Acides gras
- Lipides
- Thiazoles
- Azoles
- Suppléments alimentaires
- Nourriture
- Régime, nourriture et nutrition
- Phénomènes physiologiques
- Nourriture et boissons
- Glucides alimentaires
- Glucides
- Pyrimidines
- Polymères
- Substances macromoléculaires
- Polysaccharides
- Amidon
- Gluans
- Acides gras, insaturés
- Biopolymères
- Fructans
- Huiles
- Graisses alimentaires
- Graisses
- Graisses alimentaires, insaturés
- Thiamine
- Probiotiques
- Inuline
- Huiles de poisson
- Acides gras, oméga-3
Autres numéros d'identification d'étude
- KMU/DIR/CTU/2026/02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .