Health Condition 1: F949- Childhood disorder of social functioning, unspecified
Conditions
Interventions
Intervention1: Nichi glucan: 1gram of nichi glucan per day for 84 days
Intervention2: ECF (Gumi biotic): 1gram of ECF (Gumi biotic) per day for 84 days
Intervention3: Nichi glucan and ECF (Gumi biotic
Sponsors
Medi Nippon Health Care Private Limited MDN
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged less than 18 years 2. Both male and female 3. ASD criteria as per CARS (Childhood Autism Rating Scale) score 4. Parents willing to consent for their children for actively participating in the study
Exclusion criteria
Exclusion criteria: 1. Subjects aged more than 18 years old 2. Any child with acute general illness or is on any antibiotic, anti-inflammatory, or antioxidant treatment for the last two weeks 3. Hyperallergic to any of the investigational products 4. Subjects with long standing infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) change in the Childhood Autism Rating Scale Score and behavioral change in the subjects at the end of 12 weeks 2)Evaluation of Fecal samples for DNA extraction, PCR of 16S rRNA V3 Region and Sequencing pre and post treatment in all 4 groups 3) Evaluation of Fecal samples for pH and Serotonin levels before and at the end of study in all the groups 4) Assessment of synaptic activity before and after study in all groups through evaluation of serum synuclein levels Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events will be recorded and analysedTimepoint: adverse events will be reported as and when it occurs through telephonic conversation. further, subjects will be questioned during their visits on day 28, 56, 84 | — |
Countries
India
Contacts
Public ContactDr Raghavan Kadalraja
Kenmax Medical Service Private Limited
Outcome results
None listed