Combination of Supplements for Treating Autistic Spectrum Disorder (APITSA)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Autism Spectrum Disorder (ASD
• Intervention / Treatment: Dietary supplement: A combination of apitherapy and plant extracts; Combination product: Placebo Combination

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 040245
    • Clinica Aide Sante
  • Constanta, Romania, 900654
    • Medical Link SRL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active combination; A combination of 3 supplements with royal jelly and various plant extracts	Dietary supplement: A combination of apitherapy and plant extracts; This combination contains the active comparator
Placebo Comparator: Placebo combination; A combination of 3 products with identical look and colour	Combination product: Placebo Combination; A combination containing inert substances - placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modification on ATEC score	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	3 months each of administration of active treatment and respectively placebo
Modification of ASRS scores	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	3 months each of administration of active treatment and respectively placebo

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NSE level modifications	Changes in the levels of serum Neuron-specific enolase (NSE) will be compared between the two arms, higher levels indicate higher neuronal destruction	3 months each of administration of active treatment and respectively placebo

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Adverse effects will be noted and compared for the two study arms	3 months each of administration of active treatment and respectively placebo

Collaborators and Investigators

• Sponsor: Fundatia Bio-Forum
• Investigators: Principal Investigator: Felician Stancioiu, M.D., Fundatia Bio-Forum

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Autistic Spectrum Disorder; apitherapy; brain aromatase
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: BF-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No