CTRI/2012/11/003125RecruitingPhase 2
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 â?? A pilot study
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- CD Pharma India Pvt Ltd
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Patients with T1DM
- •18yrs of age or more(upto 65 yrs)
- •Duration of diabetes < 5 years
Exclusion Criteria
- •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
Investigators
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