Probiotic in Autism
Not Applicable
- Conditions
- Autism Spectrum Disorder
- Interventions
- Dietary Supplement: probiotic
- Registration Number
- NCT04939974
- Lead Sponsor
- All India Institute of Medical Sciences, New Delhi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description probiotic probiotic 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 probiotic Placebo packet same in colour, smell and constituent to that of placebo one packet daily for 24 weeks
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method