Combination of Supplements for Treating Autistic Spectrum Disorder

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка A combination of apitherapy and plant extracts
  This combination contains the active comparator
• Комбинированный продукт Placebo Combination
  A combination containing inert substances - placebo

Первичные конечные точки

• Modification on ATEC score [Срок оценки: 3 months each of administration of active treatment and respectively placebo]
• Modification of ASRS scores [Срок оценки: 3 months each of administration of active treatment and respectively placebo]

Вторичные конечные точки (1)

• NSE level modifications [Срок оценки: 3 months each of administration of active treatment and respectively placebo]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Румыния · 2 центра

• Clinica Aide Sante — Bucharest
• Medical Link SRL — Constanța

Публикации

• 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

Идентификаторы

NCT: NCT06756711 · BF-045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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