Effect of oral probiotic intake on immune mechanisms in children with newly diagnosed type 1 diabetes mellitus
Phase 3
- Conditions
- Health Condition 1: null- Type 1 Diabetes Mellitus
- Registration Number
- CTRI/2018/05/013581
- Lead Sponsor
- Post Graduate Institute of Medical Education and Reasearch Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children with type 1 diabetes mellitus, aged 2 to 12 years. AND
2.Diagnosed with type 1 diabetes mellitus in last six months. AND
3.Enrolled in pediatric diabetes clinic for follow-up at PGIMER, Chandigarh AND
4.Parent or legal guardian willing to give informed consent for the study.
Exclusion Criteria
1.Chronic medical condition that could affect gut microbiota (for example, Crohnâ??s disease, cystic fibrosis, irritable bowel syndrome, etc.)
2.Positive screening test for Celiac disease
3.Receiving medications or supplements that could affect gut microbiota in last 15 days (for example: broad spectrum antibiotics, pro/prebiotics, laxatives, etc.)
4.Children having diarrhea in last 2 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in regulatory-T cells (Tregs) percentage (out of total CD4+ T cells) after 6 months of probiotic treatment. <br/ ><br>2. Change in plasma interleukin-10 (IL-10) levels after 6 months of probiotic treatment. <br/ ><br>Timepoint: Base line and at 6 months of intervention
- Secondary Outcome Measures
Name Time Method 1. Change in serum C -peptide levels. <br/ ><br>2. Change in HbA1C. <br/ ><br>3. Change in insulin dose (U/kg/day). <br/ ><br>4. Change in blood glucose variability <br/ ><br> 5. GAD65, IAA, IA2 Antibody levels <br/ ><br>Timepoint: Base line and at 6 months of intervention