Probiotic in Autism
Evaluation of the Efficacy of Oral Probiotics Supplementation in Children With Autism Spectrum Disorders (ASDs): a Randomized Double Blind, Placebo Controlled Trial
1 other identifier
interventional
100
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJune 25, 2021
June 1, 2021
1 year
June 18, 2021
June 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
probiotic
ACTIVE COMPARATORThe 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
PLACEBO COMPARATORPlacebo packet same in colour, smell and constituent to that of placebo one packet daily for 24 weeks
Interventions
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 Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 25, 2021
Study Start
August 1, 2021
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
June 25, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share