Effect of synbiotic on diabetes control
Phase 3
Recruiting
- Conditions
- Type 1 Diabetes.Type 1 diabetes mellitus with ketoacidosisE10.1
- Registration Number
- IRCT20210712051866N1
- Lead Sponsor
- Rasht University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
Girls and Boys 4-18 Years
At least 6 Months after the Diagnosis of Diabetes
Being Treated with Injectable Insulin
Fasting Blod Sugar (FBS) = 126 mg/dl
Glocuse, 2 hour Post Prandial (2hpp) = 200 mg/dl
Glycated Hemoglobin (HbA1c) = 6.5%
Blood Sugar (BS) = 200 mg/dl Along with Polydipsia and Polyuria
Exclusion Criteria
Renal disease
Gastrointestinal disease
Cardiovascular disease (CVD)
Pulmonary disease
Taking antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), immunosuppressants during the last month;
Taking products containing probiotics and synbiotics or antioxidants in the last month
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood glucose level. Timepoint: Blood glucose level measurement at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage. Method of measurement: BT-3000 chemistry analyzer.;Glycated hemoglobin (HbA1c). Timepoint: Glycated hemoglobin (HbA1c) measurement at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage. Method of measurement: BT-3000 chemistry analyzer.
- Secondary Outcome Measures
Name Time Method Hypoglycemia incidence. Timepoint: Determining the hypoglycemia incidence at any time of performing the intervention. Method of measurement: Glucometer.;Incidence of Diabetic Ketoacidosis (DKA). Timepoint: Determining the Incidence of Diabetic Ketoacidosis (DKA) at any time of performing the intervention. Method of measurement: Ketone bodies level and Arterial Blood Gas.;The need for injectable insulin. Timepoint: Determining the need for injectable insulin at any time of performing the intervention. Method of measurement: Based on the patient's blood sugar using a glucometer.