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IRCT20121224011867N2 IRCT 2024-05-28 Research vice- chancellor of Tabriz university of medical sciences Investigating the effect of synbiotics in mild subclinical hypothyroid patients Synbiotic supplementation on gut microbiome metabolite, inflammatory and cardiovascular factors in mild subclinical hypothyroid patients: A double-blind placebo-controlled randomized clinical trial 2024-08-22 anticipated 48 Complete https://irct.ir/trial/76945 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Subjects are randomly assigned 1:1 into 2 intervention and placebo groups. Allocation to study groups is done based on permuted block randomization using RAS software and on random blocks that will be matched in age and sex, Blinding description: This study's main investigator and patients will be blind (synbiotic or placebo). The person is responsible for preparing the supplement (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two supplements (synbiotic and placebo) and keep the codes for himself until the end of the study and data analyses. N/A Mild subclinical hypothyroidism. Intervention 1: Intervention group: synbiotic capsule which contains bacterial species Lactobacillus rhamnoses, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus helveticus, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus gasseri, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium breve. , Bifidobacterium longum, Streptococcus thermophile and prebiotic fructooligosaccharide with a microbial load of 109 CFU after lunch once a day. Intervention 2: Control group: The placebo group will receive 1 placebo capsule per day, which includes cellulose compounds, non-absorbable silicon dioxide prepared in the Faculty of Pharmacy, after lunch for 2 months (60 days). Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: access starting 12 months after publication To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta-analysis. Where to obtain: To receive the data, contact the project manager (Naimeh Masri Alamdari). Postal address: Tabriz University of Medical Sciences - Endocrine Research Center Email: mesri65@gmail.com Academic email: n.mesri@tbzmed.ac.ir How to obtain: mesri65@gmail.com n.mesri@tbzmed.ac.ir Comments:
public Naimeh Mesri Alamdari
Endocrine Research Center, Nutrition Faculty, Attar Neishabouri Street, Golgasht Avenue
Tabriz Iran (Islamic Republic of) 5166614711 009833348939 mesri65@gmail.com Tabriz University of Medical Sciences scientific Naimeh Mesri Alamdari
ٍEndocrine Research Center, Nutrition Faculty, Attar Neishabouri Street, Golgasht Avenue
Tabriz Iran (Islamic Republic of) 5166614711 009833348939 mesri65@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Newly diagnosed patients with mild subclinical hypothyroidism TSH level between 4 and 10 IU/ml Willingness to cooperate in the project 20-65 years Suffering from mild subclinical hypothyroidism 20 years 65 years Both Hormone therapy and the use of hormonal drugs The contraceptive drugs usage The anti-inflammatory drugs usage The blood lipid-lowering drugs consumption The probiotic supplements consumption in the last 3 months before the study and during the study The antibiotic drugs usage during the study Sُynbiotic supplement intolerance during the study Immune system disorders Immunosuppressive drugs or chemotherapy consumption Cardiovascular diseases, active ulcerative colitis, short bowel syndrome, acute and chronic infectious diseases History of drug or food allergies Pregnancy and breastfeeding Smoking Alcohol consumption E02 Subclinical iodine-deficiency hypothyroidism Prevention Prevention Intervention group: synbiotic capsule which contains bacterial species Lactobacillus rhamnoses, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus helveticus, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus gasseri, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium breve. , Bifidobacterium longum, Streptococcus thermophile and prebiotic fructooligosaccharide with a microbial load of 109 CFU after lunch once a day. Control group: The placebo group will receive 1 placebo capsule per day, which includes cellulose compounds, non-absorbable silicon dioxide prepared in the Faculty of Pharmacy, after lunch for 2 months (60 days). Gut microbiome metabolite (LPS). Timepoint: Before the intervention and two months after the intervention. Method of measurement: By laboratory ELISA kits. Total cholesterol (TC). Timepoint: Before the intervention and two months after the intervention. Method of measurement: By laboratory ELISA kits. Triglyceride (TG). Timepoint: Before the intervention and two months after the intervention. Method of measurement: By laboratory ELISA kits. Apo A1. Timepoint: Before the intervention and two months after the intervention. Method of measurement: By laboratory ELISA kits. Apo B. Timepoint: Before the intervention and two months after the intervention. Method of measurement: By laboratory ELISA kits. Research vice- chancellor of Tabriz university of medical sciences Approved 2024-04-22 Research Ethics Committees of Tabriz University of Medical Sciences Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of) Approved 2024-04-22 Research Ethics Committees of Tabriz University of Medical Sciences Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)