oral Probiotic in Diabetes mellitus -type 1
Phase 3
Recruiting
- Conditions
- diabetes mellitus type 1.Type 1 diabetes mellitus
- Registration Number
- IRCT20200117046164N3
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Newly diagnosed children with type1diabetes mellitus aged between 6-18 years old.
Exclusion Criteria
Presence of comorbid conditions like significant cardiac, hepatic or renal disease
Presence of immunodeficiency
Allergy to probiotics
Patients not willing to continue participating in the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting c-peptide levels. Timepoint: before intervention and then every 3 months up to one year. Method of measurement: laboratory.;HbA1c levels. Timepoint: before intervention and then every 3 months up to one year. Method of measurement: laboratory.
- Secondary Outcome Measures
Name Time Method Anthropometric parameters. Timepoint: before intervention and then every 3 months up to one year. Method of measurement: digital scale.;Insulin requirements. Timepoint: before intervention and then every 3 months up to one year. Method of measurement: asking patient and based on prescribed insulin for glycemic control.