NCT06382909Completed
Effect of Probiotic Compound K11T e K11TMax in ASD
Effects of the Probiotic k11-tmax on Symptoms and Inflammatory Markers in Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 3 Oct 2024
Brief summary (registry, in English)
The research is characterized as a randomized, double-blind clinical trial (phase III) in which administered the probiotic K11-T (with and without added amino acids, fatty acids and vitamins) to children between 3 and 11 years old with Autism Spectrum Disorder - ASD, being subsequently assessed outcomes related to inflammatory markers and neuropsychiatric and sociopedagogical criteria. To this end, the study will create three groups, one of which will be a control group, which will receive a placebo, the other will receive the probiotic without micronutrients and another will receive the probiotic with added nutrients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 505 (actual)
- First submitted
- 28 Mar 2024
- Start date
- Mar 2024
- Primary completion date
- Jul 2024
- Lead sponsor
- Deivis de Oliveira guimaraes
- Diseases
- Autism
- NCT number
- NCT06382909
What you commit to
- Study type: Interventional
- Participants enrolled: 505
- From Mar 2024 to the primary completion date, Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Concomitant restrictive medical conditions that may interfere with the results of the study, such as serious gastrointestinal diseases, significant metabolic diseases or immunodeficiencies.
- Use of specific medications such as broad-spectrum antibiotics or immunosuppressive medications during the follow-up period.
- Previous or current participation in recent clinical studies with interventions different therapies.
Other illness
- Allergies or intolerances to components of the probiotics that will be administered.
- Uncontrolled heart conditions or serious unstable medical illnesses.
Other
- Impossibility of being present on the pre-determined assessment dates clinics.
Who the study is looking for
- Volunteers must have a confirmed diagnosis of ASD carried out by qualified professionals, in accordance with the criteria established in the Diagnostic Manual and Statistics of Mental Disorders (DSM-5) or other diagnostic classification recognized.
- The study will include children and adolescents in the specific age range of 3 to 11years.
- Be regularly enrolled in a public or private school, or in a learning center special education.
- Absence of decompensated clinical or psychiatric comorbidities;
- Informed consent: Legal guardians must provide a informed consent, understanding the study objectives, procedures involved, the risks and benefits, as well as the freedom to withdraw from the study at any time. anytime.
- Informed Assent: Children ages 7 to 11 must provide an informed consent, understanding the objectives of the study, the procedures involved, the risks and benefits, as well as the freedom to withdraw from the study at any time. anytime.
Age in the registry: 3 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gon1 gestora de Projetos Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Gon1 P&D Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
Related publications
- Kefir-derived probiotic mixture for children with autism spectrum disorder: a double-blind randomized clinical trial.BMC Pediatr · 2026 · PMID 41547752
This page is information, not medical advice. Discuss any trial with your doctor.