Diabetes. Diabetes mellitus due to underlying condition
Conditions
Interventions
Intervention 1: Intervention group: probiotic (once a day, orally) plus insulin 0.7-2 U/kg/day, subcutaneously. Intervention 2: Control group: placebo (once a day, orally) plus insulin 0.7-2 U/kg/day,
Sponsors
Bojnourd University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: Children with type 1 diabetes (diagnosis based on HbA1C higher than 6.5 or fasting blood glucose equal to 126 mg / dl in two occasions or high blood sugar levels of over 200 with symptoms of polyuria and polydipsia, Who are treated with insulin ranged from 0.7 to 2 units per kg body weight per day (types of insulin are Lantus, Novorepid, Levemir, Regular, NPH, Apidra) Age range from 3 to 14 years old 6.5<=HbA1C <=10.5 No antibiotics intake two months before enrollment No probiotic intake two weeks before enrollment No history of gastrointestinal infection two weeks before enrollment Absence of chronic gastrointestinal diseases such as inflammatory bowel disease, celiac disease, food allergies, hypothyroidism
Exclusion criteria
Exclusion criteria: Patient adherence to the treatment less than 80% for probiotics Discontinuing insulin therapy Diagnose of celiac or hypothyroidism during the therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c level. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Blood test.;Fasting blood sugar. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Blood test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: By weighting.;Height. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Ruler.;Body mass index. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: By dividing the body weight (kilograms) to the height (meters) to the power of two.;Blood pressure. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Medical manometer.;Tanner stage. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Examination.;Diabetes complications (hypoglycemia, ket-acidosis,...). Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Examination and medical history.;Side effects (abdominal pain, diarrhea, constipation, vomiting, flatulence,...). Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Examination and medical history.;Daily insulin prescription (unit/kg). Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Examination and medical history.;Calcium. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Blood test.;Phosphor. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Blood test.;Alkaline phosphatase. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Blood test.;Vitamin D. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Blood test.;Total cholesterol. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Blood test.;LDL cholesterol. Timepoint: At the beginning of the study and 3 and 6 months after that. Method of measurement: Blood test.;High-density lipoprotein. Time | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMolood Saffarirad
Bojnourd University of Medical Sciences
Outcome results
None listed