Role of good bacteria (probiotic) intake on sugar control in children with type 1 diabetes mellitus
Phase 3
Not yet recruiting
- Conditions
- Health Condition 1: null- Type 1 Diabetes Mellitus
- Registration Number
- CTRI/2017/06/008725
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Children with type 1 diabetes mellitus, aged 2 to 12 years. AND
2.Diagnosed with type 1 diabetes mellitus recently with in six months of duration.
3.Enrolled in pediatric diabetes clinic/diabetes follow up clinic of PGIMER, Chandigarh
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 diarrhoea in last 2 weeks.
5. Parents/legal guardians unwilling to give consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1cTimepoint: Baseline to 3 months after intervention
- Secondary Outcome Measures
Name Time Method 1. Change in serum C -peptide levels <br/ ><br>2. Change in insulin dose (Units/kg/day) <br/ ><br>3. Change in blood glucose variability <br/ ><br>Timepoint: Baseline to 3 months after intervention