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

22. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

68

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Rekruttering
        • Khyber Teaching Hospital
        • Ta kontakt med:
          • Dr Dur e
        • Ta kontakt med:
          • Dr Inayat Khan

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Inulin
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
Andre navn:
  • Fructan prebiotic
Kosttilskudd: Probiotic
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Andre navn:
  • Acidophilus Bifidus
Eksperimentell: 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.
Kosttilskudd: Omega-3 Fatty Acids
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
Andre navn:
  • Fish Oil, EPA, DHA
Kosttilskudd: Thiamine
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Andre navn:
  • Vitamin B1
Eksperimentell: 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.
Kosttilskudd: Inulin
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
Andre navn:
  • Fructan prebiotic
Kosttilskudd: Probiotic
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Andre navn:
  • Acidophilus Bifidus
Kosttilskudd: Omega-3 Fatty Acids
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
Andre navn:
  • Fish Oil, EPA, DHA
Kosttilskudd: Thiamine
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Andre navn:
  • Vitamin B1
Placebo komparator: Placebo Group
Participants will receive matching placebo supplements orally for 12 weeks.
Annen: Placebo
Participants will receive matching placebo supplementation orally once daily for 12 weeks.
Andre navn:
  • Matchende placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parent and Teacher ADHD Rating
Tidsramme: 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
Neuroinflammation Markers (IL-6, TNF-α)
Tidsramme: Baseline and Week 12
Change in serum levels of pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-alpha measured by ELISA
Baseline and Week 12
Neuroplasticity Markers (BDNF, Claudin-5)
Tidsramme: Baseline and Week 12
Change in brain-derived neurotrophic factor (BDNF) and blood-brain barrier tight junction protein claudin-5 measured by ELISA
Baseline and Week 12
Short-Chain Fatty Acids (SCFA)
Tidsramme: Baseline and Week 12
Change in gut microbiota-derived metabolites (e.g., butyrate) measured by ELISA
Baseline and Week 12
Complete Blood Count (CBC)
Tidsramme: Baseline and Week 12
Change in blood cell counts (e.g., white blood cells, red blood cells, platelets)
Baseline and Week 12
ADHD Diagnostic Parent and Teacher Rating
Tidsramme: Baseline and Week 12

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Khyber Medical University Peshawar

Samarbeidspartnere

Khyber Teaching Hospital

Etterforskere

  • Hovedetterforsker: Dr Dur E Shawar, PhD*, Khyber Medical University Peshawar, Pakistan
  • Hovedetterforsker: Prof Dr Inayat Shah, PhD, Khyber Medical University Peshawar, Pakistan
  • Hovedetterforsker: Prof Dr Omer Malik, PhD, Khyber Medical University Peshawar, Pakistan
  • Hovedetterforsker: Dr Madiha Khattak, PhD, Khyber Medical College

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2026

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

25. desember 2026

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

24. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KMU/DIR/CTU/2026/02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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