Probiotic in Autism

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of the Efficacy of Oral Probiotics Supplementation in Children With Autism Spectrum Disorders (ASDs): a Randomized Double Blind, Placebo Controlled Trial

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Dietary Supplement: probiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: probiotic<br>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). | Dietary Supplement: probiotic<br>* 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).<br>|
| Placebo Comparator: placebo<br>Placebo packet same in colour, smell and constituent to that of placebo one packet daily for 24 weeks | Dietary Supplement: probiotic<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 weeks |