Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children
22 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
68
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Dr Dur E Shawar, PhD*
- Número de teléfono: 03348405894
- Correo electrónico: shehwar88@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Prof Dr Inayat Shah, PhD
- Número de teléfono: 03321431414
- Correo electrónico: inayat.shah@kmu.edu.pk
Ubicaciones de estudio
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KPK
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Peshawar, KPK, Pakistán, 25000
- Reclutamiento
- Khyber Teaching Hospital
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Contacto:
- Dr Dur e
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Contacto:
- Dr Inayat Khan
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Otros nombres:
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Experimental: 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.
Otros nombres:
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Otros nombres:
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Experimental: 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.
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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.
Otros nombres:
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Otros nombres:
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
Otros nombres:
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Otros nombres:
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Comparador de placebos: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parent and Teacher ADHD Rating
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dr Dur E Shawar, PhD*, Khyber Medical University Peshawar, Pakistan
- Investigador principal: Prof Dr Inayat Shah, PhD, Khyber Medical University Peshawar, Pakistan
- Investigador principal: Prof Dr Omer Malik, PhD, Khyber Medical University Peshawar, Pakistan
- Investigador principal: Dr Madiha Khattak, PhD, Khyber Medical College
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2026
Finalización primaria (Estimado)
30 de noviembre de 2026
Finalización del estudio (Estimado)
25 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
16 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2026
Publicado por primera vez (Actual)
24 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Procesos Patológicos
- Inflamación
- Trastornos del neurodesarrollo
- Trastornos por Déficit de Atención y Conducta Disruptiva
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Neuroinflamatorias
- Trastorno por Déficit de Atención con Hiperactividad
- Compuestos de azufre
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Ácidos grasos
- Lípidos
- Tiazoles
- Azoles
- Suplementos dietéticos
- Alimento
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Comida y bebidas
- Carbohidratos dietéticos
- Carbohidratos
- Pirimidinas
- Polímeros
- Sustancias macromoleculares
- Polisacáridos
- Almidón
- Glucanos
- Ácidos grasos, insaturados
- Biopolímeros
- Fructanos
- Aceites
- Grasas dietéticas
- Grasas
- Grasas dietéticas, insaturadas
- Tiamina
- Probióticos
- Inulina
- Aceites de pescado
- Ácidos grasos, omega-3
Otros números de identificación del estudio
- KMU/DIR/CTU/2026/02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .