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
|
|
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
|
|
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. |