Health Condition 1: E109- Type 1 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Probiotics (De Simone Formulation): Arm 1: Probiotics, 1 capsule per day will be given for one year for age group 5 to 10 years. Probiotics, 2 capsule per day will be given for one year
Sponsors
Indian Council Of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients with type 1 diabetes mellitus, aged between 5 to 18 years. (2) diagnosed with type 1 diabetes in the last six months. (3) Informed consent for the study given by parent or a legal guardian.
Exclusion criteria
Exclusion criteria: Patients with any one of the following will be excluded. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Changes in diversity and relative abundances of various species of gut bacteria (alpha & beta diversity) 2) Changes in Glycemic control parameters. â?¢ serum C -peptide levels. â?¢ HbA1c. â?¢ Insulin dose (U/kg/day). â?¢ Frequency of hypoglycaemia. â?¢ Glucose VariabilityTimepoint: 1) 0,6,and 12 months 2) 0,3,6,9 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in immune regulatory parameters 2) Changes in cytokine levelsTimepoint: 0,6,and 12 months | — |
Countries
India
Contacts
Public ContactDr Rakesh Kumar
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed