Clinical trial NCT05167110: Nutritional Intervention for Children With ASD and/or ADHD
Official title: Nutritional Intervention in Children With ASD and/or ADHD: Randomized Controlled Trial With Probiotics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
ASD
Probiotics
Microbiota
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Continuous Performance Test (CPT 3 or CPT-K 2)
timeFrame: 12 weeks
measure: Social Responsiveness Scale™, Second Edition
timeFrame: 12 weeks
measure: Conners scale
timeFrame: 12 weeks
measure: Behavior Rating Inventory of Executive Function (BRIEF-2)
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical Activity (PAQ-C)
timeFrame: 12 weeks
measure: Gastrointestinal symptoms
timeFrame: 12 weeks
measure: Child Behavior Checklist (CBCL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: University Rovira i Virgili
Study officials:
affiliation: University Rovira i Virgili
name: Josefa Canals-Sans, MD
role: PRINCIPAL_INVESTIGATOR
References: