A Clinical trail to see the effect of Probiotics and Docosahexaneoic Acid on learning ability, memory and behavior in Children Aged 7â??13 Years

A randomized double-blind placebo controlled clinical trial to assess the effect of Probiotics and Docosahexaneoic Acid on cognition, concentration, memory and behavior in Children Aged 7â??13 Years

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/12/007537

Enrollment

840

Registered

2016-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Probiotics capsule and DHA softgel Capsule. : Each Probiotic capsule contains not less than 112.5 billion colony forming units (CFU) of following eight bacterial strains: Streptococcus

Eligibility

Inclusion criteria

Inclusion criteria: Healthy children, aged 7â??13 years from Government/Private school who are willing to be involved in this study will be included.

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
Improvement in cognition, concentration, memory and behaviour in children aged 7-13 years. Timepoint: Baseline to Endpoint	—

Secondary

Measure	Time frame
â?¢ The study will show if effects of treatment on behaviour or cognition are mediated by change in child sleep and bowel movements? â?¢ Will DHA or related fatty acids (assess objectively in blood sample) predict their learning, behaviour or sleep â?¢ Are any changes in behaviour or cognitive performance associated with changes in blood fatty acid status â?¢ Do sleep measures (and any changes in these) relate to objective measures of blood fatty acid status Timepoint: 0 day Baseline 120 day Endpoint	—

Measure

Time frame

â?¢ The study will show if effects of treatment on behaviour or cognition are mediated by change in child sleep and bowel movements? â?¢ Will DHA or related fatty acids (assess objectively in blood sample) predict their learning, behaviour or sleep â?¢ Are any changes in behaviour or cognitive performance associated with changes in blood fatty acid status â?¢ Do sleep measures (and any changes in these) relate to objective measures of blood fatty acid status Timepoint: 0 day Baseline 120 day Endpoint

—

Countries

India

Contacts

Public ContactDr B Santosh Kumar

National Institute of Nutrition (ICMR).

devraj.jp@rediffmail.com8712136486

Outcome results