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IRCT20200117046164N3 IRCT 2022-03-13 Mashhad University of Medical Sciences oral Probiotic in Diabetes mellitus -type 1 Investigation of efficacy of oral Probiotic in glycemic control and duration of honeymoon period in children affected by Diabetes mellitus -type 1 2022-02-24 anticipated 130 Complete https://irct.ir/trial/62136 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization will be carried out on an individual basis by Rand List software. The allocation will be seated by an independent monitor and will not be broken until the end of the study. The patients are randomly assigned to the intervention or control group. They are allocated in a 1:1 ratio to each group, Blinding description: The researchers are blinded to group assignments. After preparation of probiotic capsule, each of them will have a randomized code; then clinicians blindly administer them to patients in two groups of case and control. After data gathering, they will be analyzed blindly. All follow up data are collected by two researchers who are blinded to group assignments. The researchers who generate the randomization sequence are not involved in the treatment or future evaluation of the participants. 3 diabetes mellitus type 1. Intervention 1: Intervention group: The intervention consists of administration of probiotics to newly diagnosed children with type 1 diabetes aged 6-18 years for a six month period. Products are manufactured in the form of capsules and are supplied free of charge by ZIST TAKHMIR company, Iran. it contains these strains: Lactobacillus rhamnosus• Lactobacillus casei• Lactobacillus bulgaricus• Lactobacillus acidophilus• Bifidobacterium breve• Bifidobacterium longum • Streptococcus thermophilus10⁹CFU .Other ingredients: Fructooligosaccharides (FOS) as prebiotic,This product is gluten-free. Intervention 2: Control group: The intervention consists of administration of placebo to newly diagnosed children with type 1 diabetes aged 6-18 years for a six month period. Products are manufactured in the form of capsules and are supplied free of charge by ZIST TAKHMIR company, Iran. it contains Other ingredients of above mentioned product Fructooligosaccharides (FOS) as prebiotic,This product is gluten-free and without probiotic.The placebo is quite similar in taste and appearance to the active product. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is we not decided yet.
public Nasrin Moazzen
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
Mashhad Iran (Islamic Republic of) 91778-99191 0098 51 38049 moazzenn@mums.ac.ir Mashhad University of Medical Sciences scientific Nasrin Moazzen
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
Mashhad Iran (Islamic Republic of) 91778-99191 0098 51 38049 moazzenn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Newly diagnosed children with type1diabetes mellitus aged between 6-18 years old. 6 years 18 years Both 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 E10 Type 1 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group: The intervention consists of administration of probiotics to newly diagnosed children with type 1 diabetes aged 6-18 years for a six month period. Products are manufactured in the form of capsules and are supplied free of charge by ZIST TAKHMIR company, Iran. it contains these strains: Lactobacillus rhamnosus• Lactobacillus casei• Lactobacillus bulgaricus• Lactobacillus acidophilus• Bifidobacterium breve• Bifidobacterium longum • Streptococcus thermophilus10⁹CFU .Other ingredients: Fructooligosaccharides (FOS) as prebiotic,This product is gluten-free. Control group: The intervention consists of administration of placebo to newly diagnosed children with type 1 diabetes aged 6-18 years for a six month period. Products are manufactured in the form of capsules and are supplied free of charge by ZIST TAKHMIR company, Iran. it contains Other ingredients of above mentioned product Fructooligosaccharides (FOS) as prebiotic,This product is gluten-free and without probiotic.The placebo is quite similar in taste and appearance to the active product. 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. 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. Mashhad University of Medical Sciences Approved 2022-01-17 ethics committee of mashhad university of medical sciences Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)