The effect of probiotics supplementation on glycemic control and metabolic parameters in type 1 diabetic patients

Determining the effect of probiotic supplementation on glycemic control and metabolic parameters in type 1 diabetic patients

Double-blind controlled randomized clinical trial, with parallel groups, using double blocks for randomization.

Sampling will be done in the Diabetes and Metabolic Patients Clinic of the Institute of Endocrinology and Metabolism in Tehran. Prior to the intervention, all selected individuals enter the Run-in period for two weeks. For randomization, the subjects were aged in terms of age, the number of units of injectable insulin (maximum 6 units difference), and duration of type 1 diabetes (maximum 3 years difference) will be placed in double blocks. The individuals in each block are then divided into intervention and comparison groups.

Inclusion criteria: Having type 1 diabetes (fasting blood sugar greater than 125 mg / dL and HbA1C greater than 6.5% if confirmed by an endocrinologist) Age over 7 and under 18 years At least one year after developing type 1 diabetes Non-inclusion criteria: Have liver, kidney, inflammatory, or immunodeficiency diseases Pregnancy or breastfeeding Taking antibiotics in the last two months Consume foods containing probiotics or probiotic supplements over the past month Tobacco use or drugs Take dietary supplements or non-steroid anti-inflammatory drugs for 1 month before the study

Individuals in the probiotic supplement intervention group consisting of 6 strains of Lactobacillus, Bacillus coagulans, Bifidobacterium, and maltodextrin and the placebo group will receive one placebo, which contains maltodextrin and does not contain probiotic bacteria, one a day for 12 weeks.

HbA1C and FBS Serum levels of TG, total cholesterol, LDL-C, and HDL-C Number of units of injectable insulin blood pressure Anthropometric indicators

Block Randomization: Block randomization is intended to ensure that exactly the same number of participants enter the intervention and comparison groups at consecutive intervals. For this purpose, the subjects will be divided into double blocks in terms of age, the number of units of injection insulin (maximum 6 units difference), and duration of type 1 diabetes (maximum 3 years difference). Then the people in each block will be divided into intervention and comparison groups. In order to randomly assign individuals to groups, each person is given a code and these codes are poured into a pot. An out-of-study person is then asked to draw the codes out of the pot using a lottery. The first code of each block will be assigned to the intervention group, the second code will be assigned to the comparison group.

In this study, participants, researchers, and physicians do not know the type of intervention of placebo capsules or probiotic capsules. In this regard, one code is assigned to the placebo capsule and one code to the probiotic capsule, which is reserved by the manufacturer, and at the end of the study, the intervention and comparison groups will be identified. In this way, two people who are in a block will be given two types of capsules with different codes. Each person will be given capsules with one code and that code will be written first. After the study, the relevant person in charge of the company will be contacted and the code related to the placebo capsules and the code related to the probiotic capsules will be asked and the members of the intervention and comparison group will be identified. Placebo capsules will be no different from supplement capsules in shape, smell, color, and taste.

Only part of the participants' personal data such as information about the main outcome or the like can be shared.

Access period starts 8 months after the results are published

The data will be available to researchers working in academic and scientific institutions and to those working in industry.

No use or analysis of data and documentation is possible for any person.

Dr. Ahmad Esmailzadeh is the supervisor of the project and the data will be preserved with him. If necessary, you can refer to the Faculty of Nutrition and Dietetics of Tehran University of Medical Sciences.

The request must be in the form of a letter and stamped by the relevant body or university, and after the necessary checks, the data will be provided to them.