Autism Spectrum Disorder
Conditions
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
Interventions
DIETARY_SUPPLEMENTprobiotic
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).
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in childhood autism rating scale at 24 weeks as compared to baseline | 24 weeks | change in childhood autism rating scale at 24 weeks as compared to baseline |
Outcome results
None listed