Clinical trial NCT06756711: Combination of Supplements for Treating Autistic Spectrum Disorder
Official title: Combination of Supplements for Treating Autistic Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism Spectrum Disorder (ASD
Keywords: Autistic Spectrum Disorder
apitherapy
brain aromatase
Lead sponsor: Fundatia Bio-Forum
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective, double-blind, placebo-controlled, crossover, multicenter
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modification on ATEC score
timeFrame: 3 months each of administration of active treatment and respectively placebo
measure: Modification of ASRS scores
timeFrame: 3 months each of administration of active treatment and respectively placebo
Secondary outcomes:
measure: NSE level modifications
timeFrame: 3 months each of administration of active treatment and respectively placebo
Other outcomes:
measure: Adverse effects
timeFrame: 3 months each of administration of active treatment and respectively placebo
Locations:
city: Bucharest
country: Romania
facility: Clinica Aide Sante
city: Constanta
country: Romania
facility: Medical Link SRL
Study officials:
affiliation: Fundatia Bio-Forum
name: Felician Stancioiu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.