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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Placebo group | Placebo Comparator | Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup). |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity (PAQ-C) | 12 weeks | |
| Gastrointestinal symptoms | Discomfort/abdominal lower pain | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josefa Canals-Sans, MD | University Rovira i Virgili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Rovira i Virgili | Tarragona | 43007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39798036 | Derived | 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. |
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Results
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 30, 2025 | |
| Reset | Feb 20, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 30, 2025 | Feb 20, 2025 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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ABBiotics has been the producer of probiotics and who knows the masking
| 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). |
|
| Child Behavior Checklist (CBCL) |
emotional and behavioral symptoms |
| 12 weeks |
| D019602 |
| Food and Beverages |