Effect of Probiotic Compound K11T e K11TMax in ASD (ASD)

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Dietary supplement: Inflammatory level; Dietary supplement: Cognitive assessment; Dietary supplement: Pedagogical assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • ES
    • Vitoria, ES, Brazil, 29050335
      • Gon1 P&D
    • Vitória, ES, Brazil, 29050335
      • Gon1 gestora de Projetos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mix Probiotic K11T with out vitamins; Drug-1: K11T 1 dose/day Orally	Dietary supplement: Inflammatory level; Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage; Dietary supplement: Cognitive assessment; Neurological assessment Psychiatric assessment; Dietary supplement: Pedagogical assessment; Sociopedagogical assessment
Active Comparator: Mix Probiotic K11TMAX with vitamins; Drug-1: K11Tmax 1 dose/day Orally	Dietary supplement: Inflammatory level; Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage; Dietary supplement: Cognitive assessment; Neurological assessment Psychiatric assessment; Dietary supplement: Pedagogical assessment; Sociopedagogical assessment
Placebo Comparator: Placebo drugs; Placebo 1 dose/day Orally	Dietary supplement: Inflammatory level; Quantification of C-reactive Protein (PCR) Quantification of serum cortisol Insulin quantification Prolactin quantification Fecal calprotectin dosage; Dietary supplement: Cognitive assessment; Neurological assessment Psychiatric assessment; Dietary supplement: Pedagogical assessment; Sociopedagogical assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation biomarker 1	Quantify inflammatory markers through blood collection: Quantification of C-reactive Protein (CRP) - results in mg/dL	90 days (Day 0, Day 45 and Day 90)
Inflammation biomarker 2	Quantify inflammatory markers through blood collection: Serum Cortisol Quantification - results will be expressed in mcg/dL;	90 days (Day 0, Day 45 and Day 90)
Inflammation biomarker 3	Quantify inflammatory markers through blood collection: Insulin Quantification - the results will be expressed in mcUI/ml;	90 days (Day 0, Day 45 and Day 90)
Inflammation biomarker 4	Quantify inflammatory markers through blood collection: Prolactin Quantification - results will be expressed in ng/dL	90 days (Day 0, Day 45 and Day 90)
Inflammation biomarker 5	Quantify inflammatory markers through blood collection: Fecal Calprotectin Measurement - expressed in μg/g	90 days (Day 0, Day 45 and Day 90)
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.	90 days (Day 0, Day 45 and Day 90)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days (Day 0, Day 45 and Day 90)
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.	90 days (Day 0, Day 45 and Day 90)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax.	Comparative of all outcomes from arm k11-T and K11-Tmax. Results will be expressed in %.	90 days (Day 0, Day 45 and Day 90)

Collaborators and Investigators

• Sponsor: Deivis de Oliveira guimaraes
• Collaborators: SENAI CIMATEC
• Investigators: Study Director: Deivis O Guimaraes, PhD student, Gon1 P&D

Publications and helpful links

Helpful Links

• International Contract Research Organization
• Ethics and research committee

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Actual): July 7, 2024
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: probiotics; Biomarkers; Gut Microbiota; cognitive; asd; intestinal inflammatory
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 202302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No