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CTRI Number  CTRI/2012/11/003136 [Registered on: 22/11/2012] Trial Registered Prospectively
Last Modified On: 21/11/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Crossover Trial 
Public Title of Study   To stidy the effect of consumption of fermented synbiotic drink on the well being of geriatric volunteers 
Scientific Title of Study   Metagenomic and Clinical investigation of synbiotic fermented dairy product containing probiotic Lactobacillus helveticus MTCC 5463 in geriatric volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr JB Prajapati 
Designation  Professor and Head 
Affiliation  Department, SMC College of Dairy Science, 
Address  Dairy Microbiology Department, SMC College of Dairy Science, Anand Agricultural University, Anand

Anand
GUJARAT
388110
India 
Phone  02692264170  
Fax    
Email  prajapatijashbhai@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr JB Prajapati 
Designation  Professor and Head 
Affiliation   
Address  Dairy Microbiology Department, SMC College of Dairy Science, Anand Agricultural University, Anand
Department, SMC College of Dairy Science, Anand Agricultural University, Anand
Anand
GUJARAT
388110
India 
Phone  02692264170  
Fax    
Email  prajapatijashbhai@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr JB Prajapati 
Designation  Professor and Head 
Affiliation  Department, SMC College of Dairy Science, 
Address  Dairy Microbiology Department, SMC College of Dairy Science, Anand Agricultural University, Anand

Anand
GUJARAT
388110
India 
Phone  02692264170  
Fax    
Email  prajapatijashbhai@yahoo.com  
 
Source of Monetary or Material Support  
Department of biotechnology, Govt of India, Ministry of Science and Technology  
 
Primary Sponsor  
Name  Anand Agricultural University 
Address  Anand Agricultural University, anand - 388 110 guajrat 
Type of Sponsor  Other [Education insititute] 
 
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 Himanshu Pandya  H. M Patel Center for Medical Care & Education, Karamsad, Gujarat, India,  Central Diagnostic Laboratory (CDL), Ground floor College wing H. M Patel Center for Medical Care & Education, Karamsad, Gujarat, India,
Anand
GUJARAT 
02692222130

himanshup@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics committee, HM Patel Centre for Medical Care and Education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  digestive well being and immunity 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lactobacillus helveticus MTCC 5463   200 ml of synbiotic product fermetned with S.thermophilus MTCC 5460 and Lactobacillus helveticus MTCC 5463 and supplemented with prebiotic Honey fed daily for 4 weeks  
Comparator Agent  Placebo  200 ml of product fermetned with S.thermophilus MTCC 5460 and supplemented with prebiotic Honey fed daily for 4 weeks  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Healthy subjects of more than 60 years will be eligible for screening provided they give a signed consent form.
• Participating volunteers should be free from any chronic illness and recent illness that may compromise the immune system.
• A good health without known underlying illness. 
 
ExclusionCriteria 
Details  Use of antibiotics during past three months
Use of anti-inflammatory or immunosuppressive drugs
Use of any other drug affecting intestinal function
Details of surgery if any
Participation in any other trial before
History of gastrointestinal and immunological disorders
History of malnutrition
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
incidence of digestive disorders and improvement in immunity levels  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
metagenomic analysis of faecal microflora  1 year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   07/01/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Probiotics have established their efficacy as dietary factors which can regulate gastrointestinal functions thereby imparting health benefits to consumers. Alleviation of lactose intolerance, prevention of different forms of diarrhea, cholesterol reduction, modulation of immune functions are some of the functions attributed to probiotics. Other benefits include prevention of cancer particularly colon carcinoma and food allergy. The competitive exclusion of pathogens and reduction in number and metabolic activities of harmful organisms on one side and increasing the number and activities of beneficial organisms on other in gastrointestinal tract are considered scientific basis of probiotic functions. Among different organisms considered as probiotics Lactobacillus (L. acidophilus, L. casei, L. rhamnosus, L. helveticus etc.), Bifidobacteria (B. longum, B. bifidum) are the most successful due to their long history of use in fermented foods. The efficiency of probiotic organisms could further be enhanced by modulation of diet in such a way by incorporating components which enhance the activity of probiotics in gastrointestinal tract. These components are known as prebiotics. Due to their structure, remain undigested in upper GI tract but are acted upon selectively by probiotic organisms in lower GI tract thereby providing favorable conditions for their growth. The foods containing probiotics and prebiotics are termed as synbiotic foods and are important part of functional foods. Such foods have been applied to various categories of persons such

as pregnant women and early infancy (Allen et al, 2010), Children (Guandalini et al 2010) and healthy adults (Sierra et al, 2010). Few applications of functional foods containing probiotics have been reported in elderly persons. As population ageing is considered a significant social issue particularly in developing countries like India where the number of people over 60 years of age is increasing. WHO estimates indicate that by 2020 over 1 billion persons will be in this group. With increasing health costs and changing pattern of society in India, maintaining a healthy elderly population in country will be a future challenge. Studies indicate that nutritional factors play important role not only in delaying normal ageing but also reducing the onset of age related diseases. Old age is associated with change in function of different organs and tissues including the gastrointestinal tract. Such changes lead to loss of bone mass, poor digestion and diminished immune function. The dietary intervention containing probiotics and prebiotics may provide ideal way to improve the age related complications but this aspect has not been adequately studied. Data available to date is mostly from experimental  animals or other age groups. Few studies related to role of dietary components like oligosaccharides (Schiffrin et al, 2007 and Vulevic et al, 2008) have been conducted and reported to improve immune functions and gastrointestinal health. Considering the importance of functional foods it is imperative to study their role in age related disorders. The investigation of immune functions such as NK cell activity, cytokine production and phagocytic activity coupled with monitoring overall health through placebo controlled randomized cross over feeding trial in selected subjects will provide insights into overall role of functional foods. The molecular analysis of microbial gut diversity and metagenomic study of the gastrointestinal microbiota and its activity as well as host genome will provide reliable data to draw a conclusion.

 
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