The study is being done to see whether probiotic (good bacteria) if given to children with autism spectrum disorder has any role to play in improving behaviour and gastro-intestinal symptoms in childre
- Conditions
- Health Condition 1: F840- Autistic disorder
- Registration Number
- CTRI/2021/11/038213
- Lead Sponsor
- utri Newron Pediatrix Private limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method nilTimepoint: nil