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Nutritional Intervention for Children With ASD and/or ADHD

NCT05167110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-18

No results posted yet for this study

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.

Conditions

  • ADHD
  • ASD
  • Probiotics
  • Microbiota

Interventions

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • University Rovira i Virgili

    lead OTHER

Principal Investigators

  • Josefa Canals-Sans, MD · University Rovira i Virgili

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2022-01-10
Completion
2022-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05167110 on ClinicalTrials.gov