NCT06756711

Combination of Supplements for Treating Autistic Spectrum Disorder

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fundatia Bio-Forum · Academic / Other
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder (ASD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	A combination of apitherapy and plant extracts	This combination contains the active comparator
COMBINATION_PRODUCT	Placebo Combination	A combination containing inert substances - placebo

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-01-03
• Last updated: 2025-01-03

Locations

2 sites across 1 country: Romania