Combination of Supplements for Treating Autistic Spectrum Disorder

NCT06756711 | Enrolling By Invitation

• 1 other identifier: BF-045
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Autism Spectrum Disorder (ASD

Keywords

Autistic Spectrum Disorder; apitherapy; brain aromatase

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• NSE level modifications

  3 months each of administration of active treatment and respectively placebo

Other Outcomes (1)

• Adverse effects

  3 months each of administration of active treatment and respectively placebo

Study Arms (2)

Active combination

ACTIVE COMPARATOR

A combination of 3 supplements with royal jelly and various plant extracts

Dietary Supplement: A combination of apitherapy and plant extracts

Placebo combination

PLACEBO COMPARATOR

A combination of 3 products with identical look and colour

Combination Product: Placebo Combination

Interventions

A combination of apitherapy and plant extracts DIETARY_SUPPLEMENT

This combination contains the active comparator

Active combination

Placebo Combination COMBINATION_PRODUCT

A combination containing inert substances - placebo

Placebo combination

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundatia Bio-Forum: lead

Study Sites (2)

Clinica Aide Sante

Bucharest, 040245, Romania

Location

Medical Link SRL

Constanța, 900654, Romania

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Plant Extracts

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Felician Stancioiu, M.D.

  Fundatia Bio-Forum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, double-blind, placebo-controlled, crossover, multicenter

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 3, 2025
• Study Start: December 10, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2)