Autism Spectrum Disorder (ASD
Conditions
Keywords
Autistic Spectrum Disorder, apitherapy, brain aromatase
Brief summary
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_SUPPLEMENTA combination of apitherapy and plant extracts
This combination contains the active comparator
COMBINATION_PRODUCTPlacebo Combination
A combination containing inert substances - placebo
Sponsors
Fundatia Bio-Forum
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
prospective, double-blind, placebo-controlled, crossover, multicenter
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modification on ATEC score | 3 months each of administration of active treatment and respectively placebo | Total ATEC (Autism Treatment Evaluation Checklist) scores before and after each intervention, as well subscale scores; higher scores indicate worse status, score range between 0 (minimal, absence of pathology), to 180 - maximal intensity of symptoms |
| Modification of ASRS scores | 3 months each of administration of active treatment and respectively placebo | Scores on Autism Spectrum Rating Scales (ASRS) tests, total and 8 subscales will be compared before and after each intervention; total scores vary between 50-255, with higher score indicating more severe symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSE level modifications | 3 months each of administration of active treatment and respectively placebo | Changes in the levels of serum Neuron-specific enolase (NSE) will be compared between the two arms, higher levels indicate higher neuronal destruction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 3 months each of administration of active treatment and respectively placebo | Adverse effects will be noted and compared for the two study arms |
Countries
Romania
Outcome results
None listed