NCT05167110

Nutritional Intervention for Children With ASD and/or ADHD

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University Rovira i Virgili · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• ADHD
• ASD
• Probiotics
• Microbiota

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup).
DIETARY_SUPPLEMENT	Probiotic	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).

Timeline

• Start date: 2020-02-03
• Primary completion: 2022-01-10
• Completion: 2022-03-31
• First posted: 2021-12-22
• Last updated: 2024-01-18

Locations

1 site across 1 country: Spain