Probiotic in Autism

Not Applicable

• Conditions: Autism Spectrum Disorder

• 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

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Study First Posted: 2021-06-25
• Last Update Posted: 2021-06-25
• Study Start: 2021-08-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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