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CTRI Number  CTRI/2012/11/003125 [Registered on: 20/11/2012] Trial Registered Prospectively
Last Modified On: 25/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Probiotic VSL#3 in patients with Type-1 Diabetes Mellitus  
Scientific Title of Study   Effect of oral administration of probiotic preparation VSL#3, a clinically safe mixture of 8 strains of viable live, lyophilized lactic acid bacteria, on the metabolic control in individuals with type-1 diabetes mellitus (T1DM); a randomized, double-blind, placebo controlled trial – A pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
VSL#3-T1DM-01 dt Mar 07, 2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Tandon 
Designation  Professor 
Affiliation  AIIMS 
Address  Dept. of Endocrinology and Metabolism All India Institute of Medical Sciences (AIIMS)Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  011-26593433  
Fax    
Email  nikhil_tandon@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nikhil Tandon 
Designation  Professor 
Affiliation  AIIMS 
Address  Dept. of Endocrinology and Metabolism All India Institute of Medical Sciences (AIIMS)Ansari Nagar, New Delhi


DELHI
110029
India 
Phone  011-26593433  
Fax    
Email  nikhil_tandon@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nikhil Tandon 
Designation  Professor 
Affiliation  AIIMS 
Address  Dept. of Endocrinology and Metabolism All India Institute of Medical Sciences (AIIMS)Ansari Nagar, New Delhi


DELHI
110029
India 
Phone  011-26593433  
Fax    
Email  nikhil_tandon@hotmail.com  
 
Source of Monetary or Material Support  
CD Pharma India Pvt. Ltd. C-1/53, First Floor SDA, New Delhi - 110016 
 
Primary Sponsor  
Name  CD Pharma India Pvt Ltd 
Address  C-1/53, First Floor SDA, New Delhi - 110016 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Nikhil Tandon  Dept of Endocrinology and Metabolism  AIIMS Ansari Nagar AIIMS New Delhi 110029
South
DELHI 
01126593433

nikhil_tandon@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 1 Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo capsules  6 capsules orally thrice daily (two capsules after each meal), for 16 weeks. Capsule contains Microcrystalline cellulose 
Intervention  VSL#3 Capsules  6 capsules orally thrice daily (two capsules after each meal), for 16 weeks. Each Capsule contains 112.5 Billion CFU of live, lyophilized bacteria  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with T1DM
18yrs of age or more(upto 65 yrs)
Duration of diabetes < 5 years 
 
ExclusionCriteria 
Details  1. Patients with any other forms of diabetes
2. Pregnant and lactating women
3. Patients with chronic renal or chronic liver disease
4. Patients with any acute infective or systemic inflammatory illness
5. Illiterate patients
6. Patients unable to provide written informed consent
7. Patients with serious diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in glycosylated hemoglobin levels   16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
CGMS Results
If primary endpoints are met, cytokine ((IL-10, IL-1Beta, TNF-alpha, IFN-gamma, TGF-Beta) assessments would be done 
16 wks 
 
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 2/ Phase 3 
Date of First Enrollment (India)   26/11/2012 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Proposed study is a randomized, double-blind, placebo controlled pilot study to check for effect of oral administration of probiotic preparation VSL#3, a clinically safe mixture of 8 strains of viable live, lyophilized lactic acid bacteria, on the metabolic control in individuals with type-1 diabetes mellitus (T1DM). Type 1 diabetes mellitus is an autoimmune disease that develops in genetically predisposed individuals. Probiotics are nonpathogenic live microorganisms that, when ingested, confer health benefits to the host. Probiotics also have been shown to support the maturity of the gut immune system and could therefore support oral tolerance and protection against enteral virus infections, that is, risk factors of T1DM. A potential role for probiotics in altering the natural history of autoimmune diabetes has been suggested by a recent study. Ina study by Calcinaro et al, the authors concluded that orally administered VSL#3 prevents autoimmune diabetes and induces immunomodulation by a reduction in insulitis severity. This study is designed to see whether probiotics by virtue of their anti-inflammatory action, can inhibit ongoing beta cell destruction in already established type-1 diabetic individuals and thereby improve glycemic control.

 
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