Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Brain Biome Probiotic supplement: one sachet orally twice daily for 3 months
Control Intervention1: Placebo: one sachet orally twice a day for 3 months
Sponsors
Nutri Newron Pediatrix Private limited
Eligibility
Inclusion criteria
Inclusion criteria: All children between the ages of 2-9 years with autism spectrum disorder diagnosed with DSM 5 criteria All parents who have willingly given an informed written consent
Exclusion criteria
Exclusion criteria: Brian abnormalities detected by neurological imaging procedures Neurological syndromes or focal neurological signs history of documented sequelae of birth asphyxia or preterm less than 28 weeks gestational age or perinatal injury epilepsy -past or current significant sensory impairments like deafness/blindness use of antibiotics within 2 months prior to enrolment Chronic medical conditions Eg Diabetes, weight and height less than 3rd centile for age, long term use of anti inflammatory use within 2 months prior to enrolment Organic GI disorders like Gastro-esophageal reflux, inflammatory bowel disease or prior bowel surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of children before probiotic/placebo supplementation by Social responsiveness scale 2, Aberrant behaviour checklist, Gastro-intestinal severity index, Children sleep habits questionnaireTimepoint: at the time of initiation and after 3 months of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| nilTimepoint: nil | — |
Countries
India
Contacts
Public ContactDr Himani Narula Khanna
Hamdard Institue of Medical Science and Research
Outcome results
None listed