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IRCT20221124056594N1 IRCT 2023-02-06 Zahedan University of Medical Sciences effect of Synbiotics in Subclinical hypothyroid patients Comparison the effect of Synbiotics versus Placebo in Subclinical hypothyroid patients 2023-02-19 anticipated 40 Complete https://irct.ir/trial/67381 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients to two groups is done by permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of entry. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2, Blinding description: Double blinding method is used in this research. So that the researcher and the subjects will not be aware of the intended intervention.Patients will be treated by the drug packages predetermined by the project supervisor. The drug packages are completely similar in terms of shape and the patient and plan executive will not be aware of the contents of the packages. In the data analysis stage, the analysis will be done by the project advisor and the project manager, who are not aware of the contents of the drug packages, and only the patient group (group 1 or 2) will be determined for data analysis. Therefore, according to this working method, from the stage of entering the patient in the study to the completion of the study, data collection and information analysis, the contents of the two drug groups are not known. 3 Subclinical iodine-deficiency hypothyroidism. Intervention 1: Intervention group: All people diagnosed with subclinical hypothyroidism are randomly divided into two intervention and control (placebo) groups. After 8 weeks from the start of treatment, both groups are evaluated. As a probiotic, the drug familact from the brand of Danesh Banian bio-fermentation company, made in Iran, is used. The synbiotic capsule will contain the following 7 freeze-dried probiotic strains. Lactobacillus casei, 2 x 109 CFU Lactobacillus acidophilus, 1.5 x 109 CFU Lactobacillus Rhamnosus, 2 x 108 CFU Lactobacillus bulgaricus, 2 x 1010 CFU Bifidobacterium Breve, 7 x 109 CFU BIFIDOBACTOCTOMICS. Intervention 2: Control group: Placebo will be prepared from Danesh Bonyan bio-fermentation company, made in Iran. Placebo contains: 375 mg of starch, 22 mg of lactose, 1 mg of magnesium stearate, 1 mg of silicon dioxide and 1 mg of talc. 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 There is no further information.
public Maryam Pourmorteza
Danesh 23 Street
Zahedan Iran (Islamic Republic of) 9816144673 +98 54 3348 2233 shnosratzehi123@gmail.com Zahedan University of Medical Sciences scientific Maryam Pourmorteza
Danesh 23 Street
Zahedan Iran (Islamic Republic of) 9816144673 +98 54 3348 2233 shnosratzehi123@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Confirmation of clinical hypothyroidism based on laboratory tests of TSH, T3, T4 and Anti-TPO and confirmation of an endocrinologist Lack of indication for treatment with levothyroxine 18 years 70 years Both Having a thyroid nodule cancer Having any type of infection or inflammatory disease Absence of gastrointestinal diseases pregnancy Addiction to smoking, alcohol Use of antibiotics in the last 3 months E02 Subclinical iodine-deficiency hypothyroidism Treatment - Drugs Placebo Intervention group: All people diagnosed with subclinical hypothyroidism are randomly divided into two intervention and control (placebo) groups. After 8 weeks from the start of treatment, both groups are evaluated. As a probiotic, the drug familact from the brand of Danesh Banian bio-fermentation company, made in Iran, is used. The synbiotic capsule will contain the following 7 freeze-dried probiotic strains. Lactobacillus casei, 2 x 109 CFU Lactobacillus acidophilus, 1.5 x 109 CFU Lactobacillus Rhamnosus, 2 x 108 CFU Lactobacillus bulgaricus, 2 x 1010 CFU Bifidobacterium Breve, 7 x 109 CFU BIFIDOBACTOCTOMICS Control group: Placebo will be prepared from Danesh Bonyan bio-fermentation company, made in Iran. Placebo contains: 375 mg of starch, 22 mg of lactose, 1 mg of magnesium stearate, 1 mg of silicon dioxide and 1 mg of talc. Thyroid Hormones. Timepoint: At the beginning of the study (before the start of the intervention) and eight weeks after the start of synbiotic. Method of measurement: Fasting blood sample to measure the level of thyroid hormones by chemiluminescence method. Zahedan University of Medical Sciences Approved 2022-10-24 Ethics committee of Zahedan University of Medical Sciences Dr. Hasabi square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)