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Autism Spectrum DisorderASDNCT06382909

Effect of Probiotic Compound K11T e K11TMax in ASD

A study testing Inflammatory level, Cognitive assessment and Pedagogical assessment in people with Autism Spectrum Disorder, run by Deivis de Oliveira guimaraes at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 3 to 11 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Inflammatory level, Cognitive assessment and Pedagogical assessment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
505 participants
Where
2 sitesBrazil
Study dates
22 Mar 2024to 7 Aug 2024
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 3 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • - 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.
  • Allergies or intolerances to components of the probiotics that will be administered.
  • Previous or current participation in recent clinical studies with interventions different therapies.
  • Uncontrolled heart conditions or serious unstable medical illnesses.
  • Impossibility of being present on the pre-determined assessment dates clinics.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Gon1 gestora de Projetos

    Vitória, Espírito Santo, 29050335

  • Gon1 P&D

    Vitória, Espírito Santo, 29050335

Other trials in Brazil

About this study

Official title: Effects of the Probiotic k11-tmax on Symptoms and Inflammatory Markers in Children With Autism Spectrum Disorder

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.

Read the detailed description

To evaluate the effectiveness of probiotic compounds K11-T and K11-Tmax (enriched with amino acids, acids fatty acids and vitamins), in its solid and nano-encapsulated formulation to improve the criteria neuropsychiatric, sociopedagogical and inflammatory disorders in children with ASD.

Secondary:

  • Characterize the sample of individuals with ASD who will participate in the study through a questionnaire with sociodemographic and pedagogical data such as: Age in years; gender in percentage terms of the sample according to female or male; Weight in kg; Height in centimeters; Time since diagnosis of ASD in years and presence of psychiatric or neurological comorbidities in percentage terms of the sample.
  • Investigate the association between probiotic consumption and neuropsychological results using the scale unit validated in the literature Vineland Adaptive Behavior Scales - Third Edition (Vineland-3) in the questionnaire format answered by parents/guardians of the child with ASD;
  • Investigate the association between probiotic consumption and the change of psychiatric parameters through the application of the validated Autism Diagnostic Observation Schedule (ADOS) scale with children with ASD,
  • Investigate the association between probiotic consumption and the change of psychopedagogical parameters using the Childhood Autism Rating Scale (CARS) validated in the literature, which will be answered by the teachers responsible for each child participating in the study;
  • Analyze the possible effect of probiotics on inflammatory aspects in individuals with ASD, through serum (Insulin, C-Reactive Protein, Prolactin and Cortisol) and fecal (fecal calprotectin) biomarkers;
  • Analyze the difference of using the K11-Tmax version, enriched with supplements, on the neuropsychological, psychiatric and psychopedagogical outcomes described above in comparison to the group that used K11-Tmax alone.
Being tested
Inflammatory level, Cognitive assessment, Pedagogical assessment
Keywords
intestinal inflammatory, cognitive, probiotics, asd, Gut Microbiota, Biomarkers
Medical subject headings
Autism Spectrum Disorder, Child Development Disorders, Pervasive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inflammatory levelDietary supplement

    Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage

  • Cognitive assessmentDietary supplement

    Neurological assessment Psychiatric assessment

  • Pedagogical assessmentDietary supplement

    Sociopedagogical assessment

Study groups in NCT06382909
Study groupRoleWhat they receive
Mix Probiotic K11T with out vitaminsActive comparatorDrug-1: K11T 1 dose/day Orally
Receives: Dietary Supplement: Inflammatory level; Dietary Supplement: Cognitive assessment; Dietary Supplement: Pedagogical assessment
Mix Probiotic K11TMAX with vitaminsActive comparatorDrug-1: K11Tmax 1 dose/day Orally
Receives: Dietary Supplement: Inflammatory level; Dietary Supplement: Cognitive assessment; Dietary Supplement: Pedagogical assessment
Placebo drugsPlacebo comparatorPlacebo 1 dose/day Orally
Receives: Dietary Supplement: Inflammatory level; Dietary Supplement: Cognitive assessment; Dietary Supplement: Pedagogical assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammation biomarker 1

    Quantify inflammatory markers through blood collection:

    Quantification of C-reactive Protein (CRP) - results in mg/dL

    Measured: 90 days (Day 0, Day 45 and Day 90)

  2. Inflammation biomarker 2

    Quantify inflammatory markers through blood collection: Serum Cortisol Quantification - results will be expressed in mcg/dL;

    Measured: 90 days (Day 0, Day 45 and Day 90)

  3. Inflammation biomarker 3

    Quantify inflammatory markers through blood collection: Insulin Quantification - the results will be expressed in mcUI/ml;

    Measured: 90 days (Day 0, Day 45 and Day 90)

  4. Inflammation biomarker 4

    Quantify inflammatory markers through blood collection: Prolactin Quantification - results will be expressed in ng/dL

    Measured: 90 days (Day 0, Day 45 and Day 90)

  5. Inflammation biomarker 5

    Quantify inflammatory markers through blood collection: Fecal Calprotectin Measurement - expressed in μg/g

    Measured: 90 days (Day 0, Day 45 and Day 90)

  6. Neuropsychological Assessment

    involves a multidisciplinary approach, considering different aspects of neuropsychological functioning. Standardized analysis will be conducted using the Vineland Adaptive Behavior Scales - Vineland-3. The forms will be completed in their self-administered version by parents/caregivers and teachers, under the supervision of a qualified and trained health professional. Vineland-3 assesses adaptive behavior by dividing it into five domains: communication skills, daily living skills, socialization skills, motor skills and maladaptive/behavioral skills of the child. Those responsible will respond to the items in each domain on a scale ranging from 0 to 2, with 0 being never; 1 sometimes and 2 often. To calculate the final score, the scores are transformed into a population average of 100 based on age and a standard deviation of 15 according to the specific and standardized manual for the scale. A higher score indicates greater adaptive functioning.

    Measured: 90 days (Day 0, Day 45 and Day 90)

Secondary outcomes (2)

  1. Psychiatric Assessment

    The ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition) observational assessment will be applied. This is a standardized assessment that involves direct observation of the child in different situations and social interactions. The evaluated parameters are divided into 5 items according to the psychiatric criteria for ASD diagnoses by the Diagnostic and Statistical Manual of Mental Disorders (DSM): language and communication; reciprocal social interaction; play and imagination; stereotypical behaviors and restricted interests and, finally, atypical behaviors. The observation lasts 60 minutes and will be carried out by trained and qualified professionals supervised by a reference neuropsychologist. After applying the ADOS, the domains are coded on a scale that varies from 0 to 3 points, where 0 indicates that the child has a certain ability and 3 indicates abnormal or dysfunctional behavior.

    Measured: 90 days (Day 0, Day 45 and Day 90)

  2. Psychopedagogical Assessment

    Will be carried out using a questionnaire validated in literature in the version translated into Portuguese, called the Childhood Autism Rating Scale (CARS). It consists of a scale with fifteen parameters on the symptoms of autism spectrum disorder in children, which include: interpersonal relationships, imitation, emotional response, body use, use of objects, response to changes, visual response, auditory response, response and use of taste, smell and touch, fear or nervousness, verbal communication, non-verbal communication, level of activity, level and consistency of intellectual response and finally a general parameter of that individual's autism. Variations from 1 to 4, with number 1 corresponding to no difficulty in performing that skill until 4 being severe difficulty. If you are between 15 and 30 years old, you do not have autism; 30 to 36 mild to moderate autism and 36 to 60 correspond to severe autism.

    Measured: 90 days (Day 0, Day 45 and Day 90)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study start22 Mar 2024
  3. Primary completion7 Jul 2024
  4. Study completion7 Aug 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind, randomized, with placebo control
Masking
None (open label)
Enrolment
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06382909
Sponsor's protocol ID
202302
Acronym
ASD
Status last verified
Oct 2024
First submitted
28 Mar 2024
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • de Queiroz SAL, Guimaraes DO, Ferreira LA, Martinelli L, Werly RMM, Amorim RF, Holzbach LBSS, Badaro R, Santos AAB, Vasquez EC, Silva RS. Kefir-derived probiotic mixture for children with autism spectrum disorder: a double-blind randomized clinical trial. BMC Pediatr. 2026 Jan 17;26(1):186. doi: 10.1186/s12887-026-06515-0.

    PubMed 41547752

Questions about this trial

What is this clinical trial studying?

A study testing Inflammatory level, Cognitive assessment and Pedagogical assessment in people with Autism Spectrum Disorder, run by Deivis de Oliveira guimaraes at 2 sites in Brazil.

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 6 inclusion and 6 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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?

Inflammation biomarker 1 (time frame: 90 days (Day 0, Day 45 and Day 90)). The study lists 6 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 NCT06382909, 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 3 Oct 2024.

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