NCT05167110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

December 20, 2021

Last Update Submit

January 16, 2024

Conditions

ADHDASDProbioticsMicrobiota

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Physical Activity (PAQ-C)

    12 weeks

  • Gastrointestinal symptoms

    12 weeks

  • Child Behavior Checklist (CBCL)

    12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

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

Placebo group
ProbioticDIETARY_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).

Treatment group

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rovira i Virgili

Tarragona, 43007, Spain

Location

Related Publications (1)

  • Rojo-Marticella M, Arija V, Canals-Sans J. Effect of Probiotics on the Symptomatology of Autism Spectrum Disorder and/or Attention Deficit/Hyperactivity Disorder in Children and Adolescents: Pilot Study. Res Child Adolesc Psychopathol. 2025 Feb;53(2):163-178. doi: 10.1007/s10802-024-01278-7. Epub 2025 Jan 11.

    PMID: 39798036DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Josefa Canals-Sans, MD

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
ABBiotics has been the producer of probiotics and who knows the masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2021

First Posted

December 22, 2021

Study Start

February 3, 2020

Primary Completion

January 10, 2022

Study Completion

March 31, 2022

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

ES(1)