Nutritional Intervention for Children With ASD and/or ADHD (PRONED)

University Rovira i Virgili

Status: Completed

Conditions: ASD; Probiotics; ADHD; Microbiota

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05167110

UniversitatRoviraVirgili

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo