Nutritional Intervention for Children With ASD and/or ADHD

Study Overview
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Brief Summary
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Based on alterations in the intestinal microbiota in children with ASD and the high comorbidity between ASD and ADHD, the aim of this project was to assess whether the administration of probiotics with strains related to the production of the neurotransmitters dopamine and GABA had a positive effect on social behavior, attention, and behavior.

Detailed Description
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We hypothesized to find differences in the composition and / or function of the microbiota of the gastrointestinal tract of children with ASD and / or ADHD. We consider that the intervention with probiotics (and specifically with GABA and dopamine producing strains), can modify the composition and / or function of the GIT microbiota and change the child's behavior, partially reducing the symptoms of attention deficit, anxiety, irritability, impulsivity and restlessness associated with diagnoses and consequently, we believe that it could improve the quality of life for children and their families. Apart from the clinical evaluation of the disorder and associated psychopathological symptoms and neuropsychological deficit, the diet, lifestyle and anthropometric characteristics of the child will be evaluated, which can influence the composition and / or function of gut the microbiota. The sample that will be part of the study will be 80 children, 40 with a diagnosis of ASD and 40 with a diagnosis of ADHD. These children will randomly receive placebo or probiotic intervention for 12 weeks.

Official Title
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Nutritional Intervention in Children With ASD and/or ADHD: Randomized Controlled Trial With Probiotics.

Conditions
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ADHD, ASD, Probiotics, Microbiota

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parental informed consent, ASD and ADHD will meet the DSM diagnoses (edition IV-TR or 5) criteria Ages between 5 and 16 years To complete period (12weeks) of taking the probiotic Exclusion Criteria: Having suffered adverse effects in the previous administration of probiotics Being on probiotics 3 months before the start of the intervention To suffer any medical illness incompatible with the administration of probiotics Having intolerances or allergies to the excipient of the treatment (probiotic or placebo) Taking antibiotics in the start of the intervention.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Children assigned to the groups (ASD/ADHD) will be randomly prescribed supplementation with two GABA- and dopamine-producing strains at a total of 1 x 10 (9) CFU/capsule for 12 weeks (probiotic subgroup). | Dietary Supplement: Probiotic<br>* Children assigned to the groups (ASD/ADHD) will be randomly prescribed supplementation with two GABA- and dopamine-producing strains at a total of 1 x 10 (9) CFU/capsule for 12 weeks (probiotic subgroup).<br>|
| Placebo Comparator: Placebo group<br>Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup). | Dietary Supplement: Placebo<br>* Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Performance Test (CPT 3 or CPT-K 2) | Measures attention and inhibitory control | 12 weeks | 
| Social Responsiveness Scale™, Second Edition | Assess severity of the ASD manifestations answered by parents | 12 weeks | 
| Conners scale | Assess severity ADHD symptoms answered by parents | 12 weeks | 
| Behavior Rating Inventory of Executive Function (BRIEF-2) | Assess severity ADHD symptoms answered by parents | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity (PAQ-C) |  | 12 weeks | 
| Gastrointestinal symptoms | Discomfort/abdominal lower pain | 12 weeks | 
| Child Behavior Checklist (CBCL) | emotional and behavioral symptoms | 12 weeks |