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Do probiotics have any effect on behaviors of Autism Spectrum Disorder?

Effect of Probiotics on behavioral symptoms of Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050581
Enrollment
70
Registered
2023-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: Probiotics: Probiotics in powder formulation containing Lactobacillus sporogenes (150 Million CFU) â?? 1 sachet daily, before food taken in the morning, orally, for 12 weeks will be use

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children with ASD diagnosed on the basis of DSM-5 criteria using INCLEN 2. Age of 3 years to 16 years 3. Any gender 4. The parent/guardian giving written consent and child giving assent (for child older than7 years age) to participate in the study

Exclusion criteria

Exclusion criteria: 1. Individuals taking any pharmacological treatment that itself has impact on gut microbiota for the last three months, like antibiotics or antifungal for gut infection. 2. Children and adolescents with co-morbid mental illness diagnosed clinically such as mood disorders, psychotic illness, epilepsy, ADHD, multiple disabilities except mild intellectual disability. 3. Children and adolescents with serious medical illness like immune disorders like allergies or asthma; metabolic disorders like diabetes; heart disease; and motor disorders like cerebral palsy. 4. Those having inflammatory reactions such as diarrhea or fever; food intolerance and patients already on probiotics treatment for the past one week. 5. Children and adolescents with BMI < 5% of SD.

Design outcomes

Secondary

MeasureTime frame
NATimepoint: NA

Primary

MeasureTime frame
To determine the effect of Probiotics on core symptoms in patients with Autism Spectrum DisorderTimepoint: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 week and 12 weeks.

Countries

India

Contacts

Public ContactDr Geeta Galgat

GMCH, Sector 32, Chandigarh

drpritiarun@gmail.com9646121612

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026