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IRCT20230225057530N1 IRCT 2023-07-19 Shahid Beheshti University of Medical Sciences Evaluation of the effect of probiotics in patients with type 1 diabetes Evaluation of the effect of probiotic supplementation Saccharomyces Boulardii(babyeast) compared to placebo on HA1c level in patients with type 1 diabetes 2023-01-20 anticipated 90 Complete https://irct.ir/trial/69993 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling has been done by census method and.Patients are randomly assigned to one of the two placebo and probiotic groups, Blinding description: Babyeast sachets contain 250 mg of Saccharomyces boulardi lyophilized yeast.Placebo is also made by Knowledge enterprise biology fermentation company similar to probiotic drug and provided to the researcher. 3 Type 1 diabetes. Intervention 1: Intervention group: Babyeast sachets contain 250 mg of Saccharomyces boulardi lyophilized yeast. This product does not contain gluten or sweeteners. Each person is given 180 sachets for 6 months.90 days after the start of the study, the subjects went to the clinic, and at that time, the daily insulin consumption, the average fasting and 2-hour post-meal sugars, and HbA1c will be collected, and the drugs needed for the next 90 days will be given, and again on the 180th day of the study, the above data will be collected. is collected. Intervention 2: Control group: Placebo is also made by Knowledge Enterprise biologyfermentation company similar to probiotic drug in Babyeast sachets containing 250 mg and provided to the researcher. Yes - There is a plan to make this available What will be shared: Data can potentially be shared after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions and people working in industry Conditions: Unlimited Where to obtain: Dr. Maryam Sahrai Ardakani. 09393131367. m.sahraei67@yahoo.com. How to obtain: Unlimited Comments:
public Maryam Sahraei ardakani
Mofid hospital, Dr shariatee Ave
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7021 m.sahraei67@yahoo.com Shahid Beheshti University of Medical Sciences scientific Marjan Shakiba
Mofid Children's Hospital, Dr. Shariati Ave
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7021 shakibamarjan@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Type 1 diabetes Diagnosed 18 months before entering the study Refer to Mofid hospital clinic for routine care in 1400 2 years 18 years Both Patients do not have a history of hospitalization for medical or psychiatric reasons in the last 12 months. It is not possible to access by phone. E10.9 Type 1 diabetes mellitus without complications Treatment - Drugs Placebo Intervention group: Babyeast sachets contain 250 mg of Saccharomyces boulardi lyophilized yeast. This product does not contain gluten or sweeteners. Each person is given 180 sachets for 6 months.90 days after the start of the study, the subjects went to the clinic, and at that time, the daily insulin consumption, the average fasting and 2-hour post-meal sugars, and HbA1c will be collected, and the drugs needed for the next 90 days will be given, and again on the 180th day of the study, the above data will be collected. is collected. Control group: Placebo is also made by Knowledge Enterprise biologyfermentation company similar to probiotic drug in Babyeast sachets containing 250 mg and provided to the researcher Age Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Gender Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Patient Weight. Timepoint: At The Beginning Of The Study. Method of measurement: Scales. Height Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Meter. The Stage Of Maturation Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Patient Activity Level. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Duration Of Diagnosis Of Diabetes. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Type Of Insulin Used By The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. The Total Amount Of Insulin Received Daily. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Questionnaire-Clinical File. Fasting Blood Sugar. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory. Average Fasting Sugars. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory. Average Sugars 2 Hours After a Meal. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory. HbA1C. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory. HDL. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory. LDL. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory. Cholesterol. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory. Triglyceride. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory. Endocrine and Metabolism Research Institute, Tehran University of Medical Sciences Shahid Beheshti University of Medical Sciences Endocrine and Metabolism Research Institute, Tehran University of Medical Sciences Approved 2023-05-02 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Arabi Ave, Student Blvd, Valenjak, Tehran Tehran Tehran Iran (Islamic Republic of) Approved 2023-02-15 Ethics committee of Endocrine and Metabolism Research Institute, Tehran University of Medical Scienc Endocrinology and Metabolism Research Institute, next to Dr. Shariati Hospital, Jalal Al Ahmad Highway Tehran Tehran Iran (Islamic Republic of)