A Clinical trail to see the effect of Probiotics and Docosahexaneoic Acid on learning ability, memory and behavior in Children Aged 7â??13 Years
- Registration Number
- CTRI/2016/12/007537
- Lead Sponsor
- Department of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 840
Healthy children, aged 7â??13 years from Government/Private school who are willing to be involved in this study will be included.
1. Children with specific medical disorders (e.g. visual or hearing impairment), general learning difficulties will be excluded from the study.
2. Children who are eating fish > twice week and already taking Omega-3 will be excluded.
3. Children who are taking medicines expected to affect behavior and learning.
4. Children whoâ??s sibling will be in study.
5. Children with allergies to lactose will be excluded as probiotic capsule contains small amounts of lactose or skim milk product.
6. Children with weakened or compromised immune systems will be excluded.
7. Children will be excluded whose social/family circumstances would have made inclusion into the study inappropriate (e.g. serious illness in the family)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in cognition, concentration, memory and behaviour in children aged 7-13 years. <br/ ><br>Timepoint: Baseline to Endpoint
- Secondary Outcome Measures
Name Time Method â?¢The study will show if effects of treatment on behaviour or cognition are mediated by change in child sleep and bowel movements? <br/ ><br>â?¢Will DHA or related fatty acids (assess objectively in blood sample) predict their learning, behaviour or sleep <br/ ><br>â?¢Are any changes in behaviour or cognitive performance associated with changes in blood fatty acid status <br/ ><br>â?¢Do sleep measures (and any changes in these) relate to objective measures of blood fatty acid status <br/ ><br> <br/ ><br>Timepoint: 0 day Baseline <br/ ><br>120 day Endpoint