Comparison the effect of Synbiotics versus Placebo in Subclinical hypothyroid patients

comparing the levels of TSH, FT4, and FT3 in subclinical hypothyroid patients after treated with synbiotics versus placebo

The present study is a randomized double-blind clinical trial study that will be conducted on 40 patients. Random allocation based on the table of random numbers, the synbiotic replacement blocks and its placebo will be divided into similar boxes.

In the present study, which will be conducted at Ali Bin Abi Taleb Hospital in Zahedan, 40 patients with subclinical hypothyroidism will be included in the study. treatment will generally be done within 8 weeks. The drug packages are completely similar in terms of shape and the patient and the plan administrator will not be aware of the contents of the packages. Fasting blood samples will be taken from these people before and after receiving the supplement or placebo to measure the level of thyroid hormones.

The inclusion criteria for this study are: age between 18 and 70 years The Exclusion criteria are: lack of consent of the patients to enter the study, suffering from thyroid nodule, cancer, any type of infection or inflammatory disease, coronary artery disease, heart failure, gastrointestinal diseases, pregnancy, smoking addiction. and alcohol and antibiotic use in the last 3 monthes.

After 8 weeks from the start of treatment (taking one synbiotic or placebo pill per day), TSH, FT4, anti tpo and FT3 tests are evaluated in both intervention and control groups.

TSH, FT4, FT3 and Anti Tpo; Time to evaluate thyroid tests in patients; Subclinical hypothyroid patients treated with probiotics and patients treated with placebo

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.

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.