Nutritional Intervention for Children With ASD and/or ADHD

Not Applicable

Completed

• Conditions: ADHD; ASD; Probiotics; Microbiota
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT05167110
• Lead Sponsor: University Rovira i Virgili

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.

Study Timeline

• Study Start: 2020-02-03
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2021-12-22
• Primary Completion: 2022-01-10
• Study Completion: 2022-03-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup).
Treatment group	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Child Behavior Checklist (CBCL)	12 weeks	emotional and behavioral symptoms
Physical Activity (PAQ-C)	12 weeks
Gastrointestinal symptoms	12 weeks	Discomfort/abdominal lower pain

Trial Locations

Locations (1)

University Rovira i Virgili; 🇪🇸 Tarragona, Spain