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Enrolling by invitation NCT06756711

Combination of Supplements for Treating Autistic Spectrum Disorder

No phase Interventional Autism Spectrum Disorder (ASD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A combination of apitherapy and plant extracts, Placebo Combination.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder (ASD. Basic parameters: 3 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

A pilot study to compare the efficacy of a combination of apitherapy supplements versus placebo in children with autistic spectrum disorder.

Detailed description

A prospective, double-blind, placebo-controlled, crossover, multicentre clinical study which will enrol up to 45 children diagnosed with ASD (enrolment will stop when 40 children have completed the study). Children ages 3-14 will be tested before and after administering the combination of active substances (3 months) and placebo (3 months). The duration of participation in the study for each child will be 6 months. The supplements tested consist of three products - a combination of apitherapy and plant extracts - which have been approved for sale as individual supplements for more than 5 years in Romania - Apicol 12 gamma, Laptisor de matca activat (Royal Jelly) and Telom R Cerebral. Participation in the study is free and all children will be comparatively evaluated with the ATEC and ASRS scales and three sets of blood tests.

Interventions

  • Dietary supplement A combination of apitherapy and plant extracts
    This combination contains the active comparator
  • Combination product Placebo Combination
    A combination containing inert substances - placebo

Primary outcome measures

  • Modification on ATEC score [Time frame: 3 months each of administration of active treatment and respectively placebo]
  • Modification of ASRS scores [Time frame: 3 months each of administration of active treatment and respectively placebo]
Secondary outcome measures (1)
  • NSE level modifications [Time frame: 3 months each of administration of active treatment and respectively placebo]

Eligibility criteria

Inclusion criteria

  • age 3-14 years
  • diagnosed with typical or atypical autism spectrum disorder (F84.0 or F84.1) and received at least one therapeutic intervention before enrolling
  • the ability to follow an oral treatment, with TID/BID/QD administration
  • the availability to perform 3 sets of blood tests at a clinical laboratory within 6 months (initial, at 3- and 6-months)
  • the availability to perform 3 visits to the Investigator and 3 psychometric evaluations within 6 months

Exclusion criteria

  • patients enrolled in another interventional clinical trial currently or which ended less than 1 month prior to enrolling in this study
  • known allergy to hive products or one of the substances studied
  • inability to perform the study requirements (3 visits to the Investigator, 3 psychometric assessments, 3 sets of blood tests)
  • diagnosis of diabetes
  • history of seizures/epilepsy
  • administration of anticoagulants, antiplatelets, thrombolytic agents, low molecular weight heparins, anticonvulsants, insulin, monoamine oxidase inhibitors, non-steroidal anti-inflammatory drugs or thiazide diuretics
  • allergy to celery and other plants of the Fam. Apiaceaea (Umbelliferae)
  • abnormally elevated baseline (at V1) values of ferritin, homocysteine, HgbA1c, ESR

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Romania · 2 centers
  • Clinica Aide Sante — Bucharest
  • Medical Link SRL — Constanța

Publications

  • Stancioiu F, Bogdan R, Dumitrescu R. Neuron-Specific Enolase (NSE) as a Biomarker for Autistic Spectrum Disease (ASD). Life (Basel). 2023 Aug 13;13(8):1736. doi: 10.3390/life13081736. PMID 37629593

Identifiers

NCT: NCT06756711 · BF-045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗