FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/01/017256 [Registered on: 25/01/2019] Trial Registered Prospectively
Last Modified On: 08/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Other 
Public Title of Study   To determine the effect of Yakult Probiotic on the immunity of the study population. 
Scientific Title of Study   To Evaluate the effect of Yakult® on the Immune System of Late Middle-aged Indian Adults. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KEMHRC/Probiotic/01, Version 1.2 dated 31 Dec 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Juvekar 
Designation  Officer Incharge 
Affiliation  KEM Hospital Research Centre 
Address  Sardar Moodliar Road,
Rasta Peth,
Pune
MAHARASHTRA
411011
India 
Phone  020-66037336  
Fax    
Email  sanjay.juvekar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Juvekar 
Designation  Officer Incharge 
Affiliation  KEM Hospital Research Centre 
Address  Sardar Moodliar Road,
Rasta Peth,
Pune
MAHARASHTRA
411011
India 
Phone  020-66037336  
Fax    
Email  sanjay.juvekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Juvekar 
Designation  Officer Incharge 
Affiliation  KEM Hospital Research Centre 
Address  Sardar Moodliar Road,
Rasta Peth,
Pune
MAHARASHTRA
411011
India 
Phone  020-66037336  
Fax    
Email  sanjay.juvekar@gmail.com  
 
Source of Monetary or Material Support  
KEM Hospital Research Centre, Pune 
 
Primary Sponsor  
Name  Yakult Honsha Co Ltd 
Address  1-19, Higashi Shinbashi, 1 chome, Minato ku, Tokyo, 105 8660 Japan 
Type of Sponsor  Other [Probiotic Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Juvekar  Vadu Rural Health Program, KEM Hospital Research Centre  Vadu Budruk, Taluka Shirur, Ditrict Pune 412216
Pune
MAHARASHTRA 		 9881057959

sanjay.juvekar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KEM Hospital Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1. Resident of KEMHRC, Vadu HDSS area 2. Healthy men and women, Age between 51-60 years on the day of enrollment 3. Consented to participate.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Yakult Probiotic drink  All enrolled 30 participants will be given two bottles of Yakult® (65 ml each containing 6.5 billion Lactobacillus casei strain Shirota) on a daily basis for a total period of eight weeks. 
 
Inclusion Criteria  
Age From  51.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Resident of KEMHRC, Vadu HDSS area
2. Healthy men and women, Age between 51-60 years on the day of enrollment
3. Consented to participate.
4. Participants’ willingness and ability to comply with the requirements of the protocol.
 
 
ExclusionCriteria 
Details  1. Study participants currently enrolled in other interventional trial
2. Inability to comply with the study protocol
3. Shift or late-night workers
4. Known/reported allergy or hypersensitivity to any medicines and foods (also including allergy against dairy products)
5. Known/reported severe chronic disease (e.g. cancer, malabsorption, physician ascertained malnutrition, severe chronic infection and infestation, renal, hepatic or cardiac diseases, artificial cardiac valve, COPD (chronic obstructive pulmonary disease), respiratory insufficiency)
6. History of any cancer, HIV infection, organ transplant or any other immune system disorder
7. Acute illness (moderate or severe) and/or fever (axillary temperature ≥ 38°C or 100.4°F) at the time of enrollment or during the 7 days prior to the enrollment. (TE)
8. Known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression) or on immune suppressive drugs (within last six months)
9. Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune modifying drugs during the period starting six months prior to the enrollment. However, inhaled or topical steroids are allowed.
10. Known/reported severe neurological, cognitive or psychiatric diseases
11. Presence of acute/chronic stress (assessed as per the stress questionnaires)
12. Known/reported eating disorders (e.g. anorexia, bulimia)
13. Reported alcohol consumption with frequency more than once in a week and regular consumption of drug
14. Regular medical treatment including over the counter (OTC), which may have impact on the study aims (e.g. probiotics, laxatives etc.)
15. Receipt of any oral or injectable antibiotics 5 days before enrollment. (TE)
16. Study participants who are scheduled to undergo hospitalization during the study period
17. History of receipt of a blood transfusion, other blood products, or immune-globulins in month prior to enrollment.
18. Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled
19. Pregnant and lactating women
20. Any condition which the investigator considers sufficiently serious to interfere with the conduct of the trial or that constitutes any risk to the participants
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The effect of Yakult probiotic drink (Yakult®) on NK cell activity in Indian adults (men and women) of age group 51-60 years.   8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The effect of Yakult® on other immune parameters such as Interferon gamma cells and immunoglobulins on B cells among Indian adults (men and women) of age group 51-60 years  8 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2019 
Date of Study Completion (India) 09/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Data analysis in process.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Yakult is a functional food which is safe and being consumed in India for more than ten years now. It is backed by more than 100 human trials and has been consumed for more than 80 years by 39 million people every day. There have been no reported side effects of regular consumption of the product. One preliminary survey was undertaken in a rural Indian setting located in Pune district in a population aged 21-80 years to measure the levels of various immunological parameters including levels of NK cell activity. The findings revealed that the NK cell activity and other parameters such as IFN-γ+-producing cells (CD4 T cell, CD8 T cells, NK cell), B cells (IgA and/ IgG, plasma cell by staining with antibodies specific for – CD138, CD38 and anti-IgA or anti-IgG) among healthy Indian adults (men and women). Comparison of all the immunological parameters under consideration across age groups for adult men and women showed that the age group 51-60 years found to have low cytotoxicity of NK cell as well as low IFN- γ+ - producing NK cells and CD4+ T cells. Based on these findings and previous study age group 51-60 years seems to be the appropriate target group for enhancement in NK cell activity levels by consumption of Yakult. Thus, we concluded that the age group 51-60 years can be considered for the intervention trial of Yakult probiotic drink. The study is an intervention to evaluate the effect of a probiotic drink on the immunological parameters on Indian adults aged 51-60 years. Total 30 participants were enrolled in the study of which 29 completed the trial and one participant discontinued due to outmigration. All enrolled participants were given two bottles of Yakult® (65 ml each containing 6.5 billion Lactobacillus casei strain Shirota) on a daily basis for a total period of eight weeks. Total 30 ml of blood and up to 2ml of saliva was collected from each enrolled participant at four-time points (day 0, 28, 56, and 112 of the intervention) for immunological parameters testing and to assess the salivary IgA antibodies respectively. 

 
Close