Combination of Supplements for Treating Autistic Spectrum Disorder (APITSA)

Fundatia Bio-Forum

Status: Invitation-only

Conditions: Autism Spectrum Disorder (ASD

Treatments: Combination Product: Placebo Combination; Dietary Supplement: A combination of apitherapy and plant extracts

Study type: Interventional

Funder types: Other

Identifiers

NCT06756711

BF-045

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Active combination

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: A combination of apitherapy and plant extracts

Placebo combination

Placebo Comparator group

Description:

A combination of 3 products with identical look and colour

Treatment:

Combination Product: Placebo Combination