Probiotic VSL#3 in patients with Type-1 Diabetes Mellitus

Phase 2/3

Recruiting

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: CTRI/2012/11/003125
• Lead Sponsor: CD Pharma India Pvt Ltd

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.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-26
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with T1DM 18yrs of age or more(upto 65 yrs) Duration of diabetes < 5 years.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in glycosylated hemoglobin levels	16 weeks

Secondary Outcome Measures

Name	Time	Method
CGMS Results	If primary endpoints are met, cytokine ((IL-10, IL-1Beta, TNF-alpha, IFN-gamma, TGF-Beta) assessments would be done

Trial Locations

Locations (1)

Dept of Endocrinology and Metabolism; 🇮🇳 South, DELHI, India

Dept of Endocrinology and Metabolism

🇮🇳South, DELHI, India

Prof Nikhil Tandon

Principal investigator

01126593433

nikhil_tandon@hotmail.com