Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
Conditions
Interventions
Intervention1: SwasthyaBiome from HNC: In Phase-1, 50-cases and 50-matched controls (age- and gender-matched), aged 3-15 years, randomized 1:1, will be recruited from two centers. Metagenomic sequenci
Sponsors
Indian Council of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed ASD by a psychiatrist or pediatrician and a psychologist as per DSM-5 and or ICD-11 A score of above 70 on Indian Scale for Autism Assessment Children aged 3 to 15 years Either gender Any gastrointestinal symptoms at presentation, like constipation, diarrhea, abdominal bloating, dyspepsia, etc. Those parents who can understand the concept of the study, are consenting to participate as per the detail study methodology, including, inpatient admission, bowel cleanse procedure, colonoscopy, follow up visits and periodic telephonic calls.
Exclusion criteria
Exclusion criteria: Children with a history of brain injury, encephalitis, cerebral palsy, neuroleptic malignant syndrome, or other organic brain diseases. Children with fever have a reliance on tube feeding and accompanying emergent gastrointestinal disease that needs prompt medication. Diagnosed with severe malnutrition, body mass index below 10th percentile, body mass index above 90th percentile, excessive weight loss, or severe immunodeficiency diseases. Children with a history of severe allergies, monogenic diseases, mental disorders, or depression. Family history of chronic conditions or autoimmune diseases Children who are undergoing or have undergone synthetic prebiotics or probiotics treatment in the last 1 month or are planned for in the next 6 months. Children who had consumed antibiotics in last 3 months. Underwent FMT in last 12 months. Renal insufficiency and hepatic dysfunction, for example, alanine aminotransferase level more than 1.5 times the normal upper limits, aspartate aminotransferase level more than 1.5 times the normal upper limits, or serum creatinine level more than 1.5 times the normal upper limits. Children with significant medical problems hindering participation Parent suffering from a severe mental illness or medical illness, hindering participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short (upto 12 weeks) and long term (upto 24 weeks) efficacy of SwasthyaBiome in the behavioral symptoms in C-ASD as measured by ISAA, BSFS and P-GSAT. ii.Short (upto 12 weeks) and long term (upto 24 weeks) efficacy of SwasthyaBiome in the behavioral symptoms in C-ASD as measured by ISAA, BSFS and P-GSATTimepoint: 42 months | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Establishment of difference in the gut microbiota composition among Indian C-ASD and HNC.Timepoint: 18 months;iii. Establishment of safety and tolerability (upto 24 weeks) of SwasthyaBiome in Indian C-ASD.Timepoint: 42 months;iv. Difference in the short and long-term gut microbiota of C-ASD post-SwasthyaBiome transplantation.Timepoint: 42 months | — |
Countries
India
Contacts
Public ContactDr Kumari Rina
AIIMS Kalyani
Outcome results
None listed