Probiotic in Autism

All India Institute Of Medical Science (AIIMS)

Status: Unknown

Conditions: Autism Spectrum Disorder

Treatments: Dietary Supplement: probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04939974

probiotic autism

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

probiotic

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: probiotic

placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: probiotic