ADHDPRONEDNCT05167110
Nutritional Intervention for Children With ASD and/or ADHD
A study testing Probiotic in people with ADHD and ASD, run by University Rovira i Virgili at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, ASD, Probiotics
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ADHD, ASD, Probiotics, Microbiota
- Being tested
- Placebo, Probiotic
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Children assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Performance Test (CPT 3 or CPT-K 2)
Measures attention and inhibitory control
Measured: 12 weeks
Social Responsiveness Scale™, Second Edition
Assess severity of the ASD manifestations answered by parents
Measured: 12 weeks
Conners scale
Assess severity ADHD symptoms answered by parents
Measured: 12 weeks
Behavior Rating Inventory of Executive Function (BRIEF-2)
Assess severity ADHD symptoms answered by parents
Measured: 12 weeks
Secondary outcomes (3)
Physical Activity (PAQ-C)
Measured: 12 weeks
Gastrointestinal symptoms
Discomfort/abdominal lower pain
Measured: 12 weeks
Child Behavior Checklist (CBCL)
emotional and behavioral symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start3 Feb 2020
- Primary completion10 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josefa Canals Sans, University Rovira i Virgili
- Investigators
- Josefa Canals-Sans, MD, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167110
- Sponsor's protocol ID
- UniversitatRoviraVirgili
- Acronym
- PRONED
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Results
Publications
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.
PubMed 39798036
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention in Children With ASD and/or ADHD: Randomized Controlled Trial With Probiotics.
- ClinicalTrials.gov ID
- NCT05167110
- Acronym / sponsor ID
- PRONED / UniversitatRoviraVirgili
- Conditions
- ADHD, ASD, Probiotics, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: ProbioticChildren 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 | Dietary Supplement: PlaceboChildren assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup). |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboChildren assigned to the groups (ASD/ADHD) will be randomly prescribed placebo supplementation for 12 weeks (placebo subgroup). | Dietary supplement | Placebo group |
| ProbioticChildren 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 | Treatment group |
Primary outcome
Continuous Performance Test (CPT 3 or CPT-K 2)
Time frame: 12 weeks
Measures attention and inhibitory control
Social Responsiveness Scale™, Second Edition
Time frame: 12 weeks
Assess severity of the ASD manifestations answered by parents
Conners scale
Time frame: 12 weeks
Assess severity ADHD symptoms answered by parents
Behavior Rating Inventory of Executive Function (BRIEF-2)
Time frame: 12 weeks
Assess severity ADHD symptoms answered by parents
3 secondary outcomes
Physical Activity (PAQ-C)
Time frame: 12 weeks
Gastrointestinal symptoms
Time frame: 12 weeks
Child Behavior Checklist (CBCL)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 39798036Rojo-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.
- Individual participant dataSharing planned: Undecided. Results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josefa Canals-Sans, MD principal investigator
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with ADHD and ASD, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Performance Test (CPT 3 or CPT-K 2) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.