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Status unknownNCT04939974Updated Jun 25, 2021

Probiotic in Autism

An interventional study of probiotic in Autism Spectrum Disorder, sponsored by All India Institute of Medical Sciences, New Delhi. Status unknown. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-06-25.

Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Years to 18 Years
Sex
All
01

Study 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

02

Conditions studied

  • Autism Spectrum Disorder
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's planned enrollment of 100 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    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).

    Dietary Supplement: probiotic

  • Placebo comparator
    placebo

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

    Dietary Supplement: probiotic

Interventions

  • Dietary supplementprobiotic

    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).

06

What researchers measure

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

    Time frame: 24 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04939974
Lead sponsor
All India Institute of Medical Sciences, New Delhi
Responsible party
Sheffali Gulati (Prof, All India Institute of Medical Sciences, New Delhi) — Principal investigator
First posted
Jun 25, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Aug 1, 2022 (estimated)
Completion
Aug 1, 2022 (estimated)
Last update
Jun 25, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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