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

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

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.

Study Overview

• Status: Completed
• Conditions: ADHD; Probiotics; ASD; Microbiota
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona, Spain, 43007
    • University Rovira i Virgili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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).	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).
Placebo Comparator: Placebo group; Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup).	Dietary supplement: Placebo; Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Investigators: Principal Investigator: Josefa Canals-Sans, MD, University Rovira i Virgili

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): January 10, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: UniversitatRoviraVirgili

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No