Effect of probiotics on thyroid function and fatigue score in patients with hypothyroidism

The effect of probiotics on thyroid tests and FATIGUE SCORE in patients with hypothyroidism

Clinical trial with control group, with parallel groups, double-blind, randomized, on 80 patients

Initially, physical examination including height, weight, and BMI is performed on patients. Then, to measure the tests, including TSH, FreeT4, FreeT3, TG, CHOLESTEROL, LDL, HDL, LP (a), they are referred to the hospital laboratory. Then, patients are completely randomly divided into intervention and control groups. In the intervention group, treatment with probiotic pills is given in the amount of 500 mg capsules daily and in the control group, a placebo is prescribed. After 12 weeks, the effect of the above treatments on the initial laboratory indicators as well as on weight, blood pressure, BMI, and FATIGUE SCORE will be evaluated and compared in two groups.

Inclusion criteria: Patients with hypothyroidism, aged between 18 and 65 years, with at least 3 months of medication. patients that have taken a fixed dose of levothyroxine and are still euthyroid during this time. Exclusion criteria: History of thyroidectomy due to thyroid cancer,Have a history of taking antibiotics in the last three months,Have a history of alcohol and smoking,Be pregnant or breastfeeding,History of taking or taking levothyroxine-lowering drugs,Have levothyroxine dose changes during the study,Patient dissatisfaction to continue cooperation

Daily intake of one probiotic tablet in excess of CFU 109 equivalent to 500 mg capsules for 12 weeks

Laboratory indicators AST, ALT, ALP, BILL T, D, TG, Cholesterol, LDL, HDL, TSH, freeT4, freeT3, and The fatigue score questionnaire are checked at the beginning of the study and after 12 weeks.

In this study, block randomization will be used as a reliable randomization method that leads to a balanced allocation of individuals in treatment groups at the end of each block. For this purpose, an online website addressed as (https://www.sealedenvelope.com/simple-randomiser/v1/lists) is used to create random blocks with different sizes depending on the total sample and proposed block sizes (4 and 6). Each block content is sealed. One of the block is randomly chosen when a patient refers. The patient is assigned to one of the study arms depending on the block content. Similarly, after the completion of the first block, the second block is randomly selected and this continues until the last block and the last patient is assigned to the study arms. By assigning the last sheet of the last block, the patients are grouped equally in the two study arms.

After entering the study, patients choose a card from the secretary. They will receive placebo for even numbers and intervention medication for odd numbers. The secretary will enter the code in the form of each patient's form so the researcher and the participant will not be aware of the meaning of the code. Codes will be reserved until the end of the study and data analysis. The drug and placebo will be placed in the same boxes so the patients can not understand which are drug or placebo.