Combination of Supplements for Treating Autistic Spectrum Disorder

Not Applicable

• Conditions: Autism Spectrum Disorder (ASD

• Registration Number: NCT06756711
• Lead Sponsor: Fundatia Bio-Forum

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.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-10
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Clinica Aide Sante; 🇷🇴 Bucharest, Romania

Medical Link SRL; 🇷🇴 Constanta, Romania