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Probiotic in Autism

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
probiotic
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All children diagnosed with Autistic Spectrum Disorders by DSM 5 criteria
  2. Aged: 2-18 years.
  3. Normal hearing (clinically or whenever required by Oto-acoustic emission / automated Brainstem evoked response audiometry)
  4. Preferably patients from Delhi-NCR or ready to come for follow up -

Exclusion Criteria:

  • On standard treatment and care for more than 12 weeks 2. Received in last 12 weeks or currently on any complementary and/or alternate therapy including dietary therapy 3. Associated chronic systemic illness 4. Known allergy to any component of probiotic supplement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    probiotic

    placebo

    Arm Description

    The probiotic preparation selected for this study will contain use three species of probiotic bacterias namely Lactobacillus rhamnosus - ATCC 21052, Lactobacillus plantarum - ATCC 8014 and Bifidobacterium longum subsp. Infantis-ATCC 15707 at the dose of one billion (10 9 ) CFU/g of product (Total 3x10 9 CFU/g).

    Placebo packet same in colour, smell and constituent to that of placebo one packet daily for 24 weeks

    Outcomes

    Primary Outcome Measures

    change in childhood autism rating scale at 24 weeks as compared to baseline
    change in childhood autism rating scale at 24 weeks as compared to baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    June 18, 2021
    Last Updated
    June 18, 2021
    Sponsor
    All India Institute of Medical Sciences, New Delhi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04939974
    Brief Title
    Probiotic in Autism
    Official Title
    Evaluation of the Efficacy of Oral Probiotics Supplementation in Children With Autism Spectrum Disorders (ASDs): a Randomized Double Blind, Placebo Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2022 (Anticipated)
    Study Completion Date
    August 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    All India Institute of Medical Sciences, New Delhi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    One suitable probiotic packet will be administered to one group and placebo to another group of autism children and improvement in CARS will be monitored

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    probiotic
    Arm Type
    Active Comparator
    Arm Description
    The probiotic preparation selected for this study will contain use three species of probiotic bacterias namely Lactobacillus rhamnosus - ATCC 21052, Lactobacillus plantarum - ATCC 8014 and Bifidobacterium longum subsp. Infantis-ATCC 15707 at the dose of one billion (10 9 ) CFU/g of product (Total 3x10 9 CFU/g).
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo packet same in colour, smell and constituent to that of placebo one packet daily for 24 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    probiotic
    Intervention Description
    The probiotic preparation selected for this study will contain use three species of probiotic bacterias namely Lactobacillus rhamnosus - ATCC 21052, Lactobacillus plantarum - ATCC 8014 and Bifidobacterium longum subsp. Infantis-ATCC 15707 at the dose of one billion (10 9 ) CFU/g of product (Total 3x10 9 CFU/g).
    Primary Outcome Measure Information:
    Title
    change in childhood autism rating scale at 24 weeks as compared to baseline
    Description
    change in childhood autism rating scale at 24 weeks as compared to baseline
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All children diagnosed with Autistic Spectrum Disorders by DSM 5 criteria Aged: 2-18 years. Normal hearing (clinically or whenever required by Oto-acoustic emission / automated Brainstem evoked response audiometry) Preferably patients from Delhi-NCR or ready to come for follow up - Exclusion Criteria: On standard treatment and care for more than 12 weeks 2. Received in last 12 weeks or currently on any complementary and/or alternate therapy including dietary therapy 3. Associated chronic systemic illness 4. Known allergy to any component of probiotic supplement

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Probiotic in Autism

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