Probiotic in Autism

All India Institute of Medical Sciences100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Autism Spectrum Disorder

Interventions

probioticDIETARY_SUPPLEMENT

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).

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 24 weeks

Data from ClinicalTrials.gov

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