Probiotic in Autism

NCT ID: NCT04939974

Last Updated: 2021-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-08-01

Brief Summary

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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

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Placebo packet same in colour, smell and constituent to that of placebo one packet daily for 24 weeks

Group Type PLACEBO_COMPARATOR

probiotic

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sheffali Gulati

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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probiotic autism

Identifier Type: -

Identifier Source: org_study_id

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