Neurodevelopmental DisordersNCT06352203
Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients
A study testing Probiotic in people with Neurodevelopmental Disorders, run by ProbiSearch SL at 1 site in Spain.
Trial summary
Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 12 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 7 years old.
- Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification.
- Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).
- Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.
Who cannot join
- With intake of antibiotics in the last month.
- With intake of probiotics in the last two weeks.
- Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.
- Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).
- Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc.
- Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
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- Congenital or acquired immunodeficiency.
- Immunocompromised (e.g., cancer and/or transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system).
- Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol.
- With oral hyper sensitivity impairments that prevent the uptake of the study product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.
Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.
An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.
The duration of the study will be of 6 months approximately, including 6 months of product intake.
Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
1 dose of the probiotic every 24 hours, for 6-months.
PlaceboDietary supplement
1 dose of the placebo every 24 hours, for 6-months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Not described Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with intestinal dysbiosis after 6 months of treatment.
Measured: After 6 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start12 Apr 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352203
- Sponsor's protocol ID
- AUT/23.02
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.
- ClinicalTrials.gov ID
- NCT06352203
- Acronym / sponsor ID
- AUT/23.02
- Conditions
- Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (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.
Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.
An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.
The duration of the study will be of 6 months approximately, including 6 months of product intake.
Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3 to 7 years old.
- Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification.
- Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).
- Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.
Key exclusion criteria (10 listed)
- With intake of antibiotics in the last month.
- With intake of probiotics in the last two weeks.
- Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.
- Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).
- Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc.
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 |
|---|---|---|
| Probiotic1 dose of the probiotic every 24 hours, for 6-months. | Dietary supplement | Probiotic |
| Placebo1 dose of the placebo every 24 hours, for 6-months. | Dietary supplement | Placebo |
Primary outcome
Number of children with intestinal dysbiosis after 6 months of treatment.
Time frame: After 6 months of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neurodevelopmental Disorders, run by ProbiSearch SL 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 10 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of children with intestinal dysbiosis after 6 months of treatment. (time frame: After 6 months of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.