Health Condition 1: F80-F89- Pervasive and specific developmental disorders
Conditions
Interventions
Intervention1: Probiotic - Lactobacillus rhamnosus GG (LGG): The intervention involves the daily supplementation of Lactobacillus rhamnosus GG (LGG), a widely studied probiotic strain, at a dosage of
Sponsors
AIIMS Guwahati
Indian Council of Medical Research ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1 Children aged 3 to 14 years 2 Confirmed diagnosis of Autism Spectrum Disorder ASD based on DSM V criteria 3 Written informed consent provided by parents or legal guardians 4 Participants and their families are willing to comply with study procedures and intervention schedule
Exclusion criteria
Exclusion criteria: 1 Children with renal pulmonary cardiac or hepatic dysfunction that could impact study outcomes 2 Presence of intellectual disability or global developmental delay unrelated to Autism Spectrum Disorder ASD 3 Weight for length or height for age less than 3 standard deviations below the mean based on WHO growth charts 4 Recent use of antibiotics within two months prior to enrollment 5 Use of probiotics or probiotic supplements within the past six months 6 History of inflammatory bowel disease celiac disease eosinophilic disorders eg eosinophilic esophagitis or prior bowel surgery 7 Current use of chronic anti inflammatory medications within two months before enrollment 8 Families unable to adhere to study procedures intervention schedules or follow up assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Overall Quality of Life (QoL): Metric: Measured using the Quality-of-Life Autism (QoLA) questionnaire, designed to assess the well-being of children with Autism Spectrum Disorder (ASD) and their families. Timepoint: Assessed at baseline (pre-intervention) and 12 weeks (post-intervention). | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavioral Improvements: Metric: Assessed using the Childhood Behavior Checklist (CBCL) and Autism Treatment Evaluation Checklist (ATEC) to evaluate reductions in anxiety, aggression, and irritability.Timepoint: Measured at baseline and 12 weeks post-intervention.;Family Functioning: Metric: Evaluated using the Brief Autism Mealtime Behavior Inventory (BAMBI) to assess improvements in family interactions during mealtimes.Timepoint: Assessed at baseline (pre-intervention) and 12 weeks (post-intervention).;Gut Microbiome Modulation: Metric: Changes in gut microbiota composition and diversity analyzed using 16S rRNA gene sequencing of stool samples.Timepoint: Assessed at baseline and 12 weeks post-intervention. | — |
Countries
India
Contacts
Public ContactMurchana Khound
AIIMS Guwahati
Outcome results
None listed