In this study, several markers will be examined:
Blood markers: The test will assess various potential markers through the analysis of a 10 ml blood sample, which is approximately two teaspoons. For those interested, there will be an option to conduct comprehensive genetic testing for both parents and the child (exome trio) using the same blood sample.
Breath analysis: The test will measure a range of proteins (proteome) in the exhaled breath.
Fecal microbiome analysis: Children with autism have been found to have changes in the composition of their gut microbiome, which may be related to different behavioral manifestations. A special stool kit and assistance in sample collection will be provided, and the sample will be collected by a courier (no refrigeration needed). Results will be provided after the analysis.
Sleep quality assessment: The quality of sleep over five nights will be evaluated using a suitable device - Fitbit. After the assessment, the results will indicate the child's sleep latency, frequency of night awakenings, time spent awake at each awakening, duration of each sleep stage, and more. The Fitbit device will be collected by a courier.
Eye tracking assessment: Computerized measurement of eye movements and gaze width during the observation of a short video. Children with autism tend to focus less on eyes, faces, and biological movements compared to non-biological movements, shapes, etc.
Parents will complete a brief questionnaire to assess autism-related characteristics.
Children aged 2-4 years will have the option to undergo a psychological evaluation and medical assessment necessary for diagnosis (if not already performed).
Participating children will receive a modest reward (a toy valued at 50 ₪) for their consent to participate in the research. Parents will receive compensation of 250 ₪ as reimbursement for their time spent participating (the payment will be directly transferred to their bank account).
If you are interested in participating in the study, please contact the research coordinator, Lola Polyansky Strik, via email: at lolapolyansky@gmail.com, or by phone: at 050-4944664.
The Impact of Combined Cannabidiol and Nutritional Supplements ("Neuroprotactive Cocktail") Treatment on Behavioral and Communication Problems in Children with Autism - Morning Study
The research has not yet begun. If you wish to be on the waiting list for the study, please contact the research coordinator, Lola Polyansky Strik, at lolapolyansky@gmail.com.
The Impact of Combined Cannabidiol and Nutritional Supplements ("Neuroprotactive Cocktail") Treatment on Behavioral and Communication Problems in Children with Autism - Morning Study
Background: Due to the heterogeneity of Autism Spectrum Disorder (ASD) in terms of clinical presentation and underlying causes, attempts to find a single pharmacological compound that assists with core ASD symptoms have not been successful thus far.
The objective of the research: To examine the impact of a neuro-protective cocktail containing cannabidiol (CBD), sulforaphane (SFN), and various nutritional supplements on children with ASD in a morning study compared to a placebo ("non-active substance").
Research description: One hundred children with ASD and behavioral problems will be randomly assigned (in a 1:1 ratio) to receive either a placebo or a neuro-protective cocktail. The treatment will be added to their existing therapy for 12 weeks. Participants who complete the morning study will be eligible to participate in a subsequent open-label study for an additional 12 weeks (a study in which all participants receive the experimental treatment rather than a placebo).
Main inclusion criteria: Diagnosis of ASD according to DSM-5 and ADOS-2 criteria; ages 4-13 years; body weight between 12.5 kg and 57.5 kg.
Importance: Behavioral difficulties are a common problem among children with ASD. They exacerbate social impairment, complicate therapeutic interventions, and cause significant challenges for families and caregivers. Currently, there is no approved pharmacological treatment for core ASD symptoms. Anti-psychotic drugs are commonly prescribed for behavioral challenges, but they often lead to weight gain and metabolic disturbances. In this proposed research, the potential of a combined neuroprotective, anti-inflammatory, and antioxidant cocktail will be examined. Each of the components has previously shown benefits for children with ASD in morning studies, but their combined effect has never been tested. Positive results from this research may lead to more effective treatment options for ASD, potentially leading to a significant improvement in the quality of life for patients and their families and reducing the high costs associated with their treatment.