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
|
|
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
|
|
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. |