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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  
Name  Address 
 
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.

 
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