CTRI Number |
CTRI/2016/12/007537 [Registered on: 06/12/2016] Trial Registered Prospectively |
Last Modified On: |
25/03/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Probiotic |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Clinical trail to see the effect of Probiotics and Docosahexaneoic Acid on learning ability, memory and behavior in Children Aged 7–13 Years |
Scientific Title of Study
Modification(s)
|
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 7–13 Years |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Devaraj Parasannanavar |
Designation |
Scientist B |
Affiliation |
National Institute of Nutrition (ICMR). |
Address |
Department of Microbiology and Immunology.
National Institute of Nutrition (ICMR).
Jamai - Osmania,Tarnaka, Hyderabad.
Hyderabad ANDHRA PRADESH 500007 India |
Phone |
8712136486 |
Fax |
040-27019074 |
Email |
devraj.jp@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Devaraj Parasannanavar |
Designation |
Scientist B |
Affiliation |
National Institute of Nutrition (ICMR). |
Address |
Department of Microbiology and Immunology.
National Institute of Nutrition (ICMR).
Jamai - Osmania,Tarnaka, Room no B-24, staff qtrs,National Institute of Nutrition cam
Jamai-osmania,Tarnaka Hyderabad ANDHRA PRADESH 500007 India |
Phone |
8712136486 |
Fax |
040-27019074 |
Email |
devraj.jp@rediffmail.com |
|
Details of Contact Person Public Query
Modification(s)
|
Name |
Dr B Santosh Kumar |
Designation |
SCIENTIST C |
Affiliation |
National Institute of Nutrition (ICMR). |
Address |
Drug Safety Division,
National Institute of Nutrition (ICMR).
Jamai - Osmania,Tarnaka,
Hyderabad TELANGANA 500 007 India |
Phone |
9885767609 |
Fax |
040-27019329 |
Email |
drsantoshkumar999@gmail.com |
|
Source of Monetary or Material Support
|
Department of Health Research,Ministry of Health and Family welfare,Govt of India.
|
National Institute of Nutrition, Hyderabad. |
|
Primary Sponsor
|
Name |
Department of Health Research |
Address |
Ministry of Health and Family welfare,Govt of India.
2nd Floor,IRCS building,Red Cross Road,New Delhi-110001 |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Devraj Parasannanavar |
Government Primary schools in and around Secunderabad and Hyderabad. |
National Institute of Nutrition,Jamai-osmania,Tarnaka Hyderabad ANDHRA PRADESH |
8712136486 040-27019074 devraj.jp@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee, National Institute of Nutrition. |
Approved |
|
Regulatory Clearance Status from DCGI
|
Status |
No Objection Certificate |
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Healthy Human Volunteers |
Apparently Healthy children of age 7-13 years of age |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
DHA placebo |
DHA placebo contains sunflower oil which is identical in dimensions, taste, appearance and colour |
Comparator Agent |
Probiotic Placebo and DHA placebo |
Probiotic Placebo contains Microcrystalline Cellulose and DHA placebo contains sunflower oil which is identical in dimensions, taste, appearance and colour |
Intervention |
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 thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus delbrueckii subsp. bulgaricus.
Each DHA capsule contains 300mg of DHA.
|
|
Inclusion Criteria
Modification(s)
|
Age From |
7.00 Year(s) |
Age To |
13.00 Year(s) |
Gender |
Both |
Details |
Healthy children, aged 7–13 years from Government/Private school who are willing to be involved in this study will be included. |
|
ExclusionCriteria |
Details |
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 who’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)
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Improvement in cognition, concentration, memory and behaviour in children aged 7-13 years.
|
Baseline to Endpoint |
|
Secondary Outcome
|
Outcome |
TimePoints |
• The study will show if effects of treatment on behaviour or cognition are mediated by change in child sleep and bowel movements?
• Will DHA or related fatty acids (assess objectively in blood sample) predict their learning, behaviour or sleep
• Are any changes in behaviour or cognitive performance associated with changes in blood fatty acid status
• Do sleep measures (and any changes in these) relate to objective measures of blood fatty acid status
|
0 day Baseline
120 day Endpoint |
|
Target Sample Size
Modification(s)
|
Total Sample Size="840" Sample Size from India="840"
Final Enrollment numbers achieved (Total)= "840"
Final Enrollment numbers achieved (India)="840" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
04/12/2017 |
Date of Study Completion (India) |
24/03/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Normal cognitive abilities like attention, concentration and memory are essential factors which directly or indirectly determine the scholastic and overall achievements of an individual not only in terms of schooling, but also in their earning capacity and therefore GDP and economic growth of the country. Intestinal microbiota is increasingly recognized as a complex signaling network which has critical role in cognitive functions including learning, memory and decision making processes. A novel recent study implicated the vagus nerve in the direct communication observed between the gut bacteria and the brain (Bravo J A. et al., 2011). Studies have shown that probiotics improve memory, mood and cognition (Logan and Katzman, 2005, D Benton 2007). Docosahexaneoic Acid (DHA) is considered as “essential nutrient†both for children and adults, it is a key structural and physiologically active component of the brain, retina and neurons. Dietary intake of DHA, in most parts of the world, falls short of international recommendations (J. T. Winkler 2013). The supplementation of DHA in the diet modulates neurotransmission, gene expression and signal transduction improvements. Proposed study will address weather combination of both probiotic and DHA supplementation will improve cognition, concentration, memory and behavior in children 7-9 years of age. Supplementing DHA and probiotic will also help in other health benefits as these are known anti- inflammatory, immunomodulater and improve mineral absorption. This study will provide evidence base for the role of dietary supplements in enhancing cognition (student performance) which intern helps to earn more and improves GDP and economic growth of the country. This could lead to a more systematic approach to raising achievement and improving behavior in mainstream schools by early intervention. |