Effect of Probiotic Compound K11T e K11TMax in ASD

NCT06382909 | Completed DMC

• 1 other identifier: 202302
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Autism Spectrum Disorder

Keywords

intestinal inflammatory; cognitive; probiotics; asd; Gut Microbiota; Biomarkers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Psychiatric Assessment

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

• Psychopedagogical Assessment

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

Other Outcomes (1)

• Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax.

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

Study Arms (3)

Mix Probiotic K11T with out vitamins

ACTIVE COMPARATOR

Drug-1: K11T 1 dose/day Orally

Dietary Supplement: Inflammatory level; Dietary Supplement: Cognitive assessment; Dietary Supplement: Pedagogical assessment

Mix Probiotic K11TMAX with vitamins

ACTIVE COMPARATOR

Drug-1: K11Tmax 1 dose/day Orally

Dietary Supplement: Inflammatory level; Dietary Supplement: Cognitive assessment; Dietary Supplement: Pedagogical assessment

Placebo drugs

PLACEBO COMPARATOR

Placebo 1 dose/day Orally

Dietary Supplement: Inflammatory level; Dietary Supplement: Cognitive assessment; Dietary Supplement: Pedagogical assessment

Interventions

Inflammatory level DIETARY_SUPPLEMENT

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

Mix Probiotic K11T with out vitamins; Mix Probiotic K11TMAX with vitamins; Placebo drugs

Cognitive assessment DIETARY_SUPPLEMENT

Neurological assessment Psychiatric assessment

Mix Probiotic K11T with out vitamins; Mix Probiotic K11TMAX with vitamins; Placebo drugs

Pedagogical assessment DIETARY_SUPPLEMENT

Sociopedagogical assessment

Mix Probiotic K11T with out vitamins; Mix Probiotic K11TMAX with vitamins; Placebo drugs

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Deivis de Oliveira guimaraes: lead
• SENAI CIMATEC: collaborator

Study Sites (2)

Gon1 gestora de Projetos

Vitória, Espírito Santo, 29050335, Brazil

Location

Gon1 P&D

Vitória, Espírito Santo, 29050335, Brazil

Location

Related Links

• International Contract Research Organization
• Ethics and research committee

MeSH Terms

Conditions

Autism Spectrum Disorder; Child Development Disorders, Pervasive

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Deivis O Guimaraes, PhD student

  GON1 P&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research

Model Details: Double blind, randomized, with placebo control

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 24, 2024
• Study Start: March 22, 2024
• Primary Completion: July 7, 2024
• Study Completion: August 7, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)