Probiotic in Autism

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04939974
• Other study ID #: probiotic autism
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2021
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Dietary Supplement:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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