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Completed

NCT Number: NCT05167110

Nutritional Intervention for Children With ASD and/or ADHD

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.

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Key information

Conditions

ADHD ASD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Microbiota Neurodevelopmental Disorders Probiotics

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rovira i Virgili

Tarragona, 43007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

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

Probiotic

Dietary Supplement

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 outcomes

  1. Continuous Performance Test (CPT 3 or CPT-K 2)

    Time frame: 12 weeks

    Measures attention and inhibitory control

  2. Social Responsiveness Scale™, Second Edition

    Time frame: 12 weeks

    Assess severity of the ASD manifestations answered by parents

  3. Conners scale

    Time frame: 12 weeks

    Assess severity ADHD symptoms answered by parents

  4. Behavior Rating Inventory of Executive Function (BRIEF-2)

    Time frame: 12 weeks

    Assess severity ADHD symptoms answered by parents

Secondary outcomes

  1. Physical Activity (PAQ-C)

    Time frame: 12 weeks

  2. Gastrointestinal symptoms

    Time frame: 12 weeks

    Discomfort/abdominal lower pain

  3. Child Behavior Checklist (CBCL)

    Time frame: 12 weeks

    emotional and behavioral symptoms

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Registry information

Official study title

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

Acronym: PRONED

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2021
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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