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

22 juni 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

68

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Rekrytering
        • Khyber Teaching Hospital
        • Kontakt:
          • Dr Dur e
        • Kontakt:
          • Dr Inayat Khan

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kosttillskott: Inulin
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
Andra namn:
  • Fructan prebiotic
Kosttillskott: Probiotic
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Andra namn:
  • Acidophilus Bifidus
Experimentell: 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.
Kosttillskott: 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.
Andra namn:
  • Fish Oil, EPA, DHA
Kosttillskott: Thiamine
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Andra namn:
  • Vitamin B1
Experimentell: 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.
Kosttillskott: Inulin
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
Andra namn:
  • Fructan prebiotic
Kosttillskott: Probiotic
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
Andra namn:
  • Acidophilus Bifidus
Kosttillskott: 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.
Andra namn:
  • Fish Oil, EPA, DHA
Kosttillskott: Thiamine
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Andra namn:
  • Vitamin B1
Placebo-jämförare: Placebo Group
Participants will receive matching placebo supplements orally for 12 weeks.
Övrig: Placebo
Participants will receive matching placebo supplementation orally once daily for 12 weeks.
Andra namn:
  • Matchande placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Parent and Teacher ADHD Rating
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline and Week 12
Change in gut microbiota-derived metabolites (e.g., butyrate) measured by ELISA
Baseline and Week 12
Complete Blood Count (CBC)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Khyber Medical University Peshawar

Samarbetspartners

Khyber Teaching Hospital

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2026

Primärt slutförande (Beräknad)

30 november 2026

Avslutad studie (Beräknad)

25 december 2026

Studieregistreringsdatum

Först inskickad

16 juni 2026

Först inskickad som uppfyllde QC-kriterierna

22 juni 2026

Första postat (Faktisk)

24 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KMU/DIR/CTU/2026/02

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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