Nutritional Intervention for Children With ASD and/or ADHD

University Rovira i Virgili80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

ADHD ASD Probiotics Microbiota

Interventions

PlaceboDIETARY_SUPPLEMENT

Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup).

ProbioticDIETARY_SUPPLEMENT

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).

Eligibility

Sex: ALLMin age: 4 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Rovira i Virgili

Tarragona, Spain

Outcomes

Primary Outcomes

Continuous Performance Test (CPT 3 or CPT-K 2)

Measures attention and inhibitory control

Time frame: 12 weeks

Social Responsiveness Scale™, Second Edition

Assess severity of the ASD manifestations answered by parents

Time frame: 12 weeks

Conners scale

Assess severity ADHD symptoms answered by parents

Time frame: 12 weeks

Behavior Rating Inventory of Executive Function (BRIEF-2)

Assess severity ADHD symptoms answered by parents

Time frame: 12 weeks

Secondary Outcomes

Physical Activity (PAQ-C)

Time frame: 12 weeks

Gastrointestinal symptoms

Discomfort/abdominal lower pain

Time frame: 12 weeks

Child Behavior Checklist (CBCL)

emotional and behavioral symptoms

Time frame: 12 weeks

Data from ClinicalTrials.gov

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