Probiotic VSL#3 in patients with Type-1 Diabetes Mellitus
Phase 2
- Conditions
- Health Condition 1: null- Type 1 Diabetes Mellitus
- Registration Number
- CTRI/2012/11/003125
- Lead Sponsor
- CD Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in glycosylated hemoglobin levelsTimepoint: 16 weeks
- Secondary Outcome Measures
Name Time Method CGMS Results <br/ ><br>If primary endpoints are met, cytokine ((IL-10, IL-1Beta, TNF-alpha, IFN-gamma, TGF-Beta) assessments would be doneTimepoint: 16 wks