Nutritional Intervention for Children With ASD and/or ADHD

ADHD Clinical Trial

— PRONED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167110
• Other study ID #: UniversitatRoviraVirgili
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2024
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 31, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• ASD
• Microbiota
• Probiotics

Intervention

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

Locations

Country	Name	City	State
Spain	University Rovira i Virgili	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Performance Test (CPT 3 or CPT-K 2)	Measures attention and inhibitory control	12 weeks
Primary	Social Responsiveness Scale™, Second Edition	Assess severity of the ASD manifestations answered by parents	12 weeks
Primary	Conners scale	Assess severity ADHD symptoms answered by parents	12 weeks
Primary	Behavior Rating Inventory of Executive Function (BRIEF-2)	Assess severity ADHD symptoms answered by parents	12 weeks
Secondary	Physical Activity (PAQ-C)		12 weeks
Secondary	Gastrointestinal symptoms	Discomfort/abdominal lower pain	12 weeks
Secondary	Child Behavior Checklist (CBCL)	emotional and behavioral symptoms	12 weeks