Background: The prevalence of hypothyroidism is increasing worldwide. Emerging evidence suggests that modulating the gut microbiota in patients with hypothyroidism through prebiotic and probiotic supplementation may have beneficial health effects. We hypothesize that selective modulation of the intestinal microbiota by synbiotic supplementation could improve metabolic status, mood, and quality of life in hypothyroid patients.
Methods: Fifty-six patients with immune and non-immune-related hypothyroidism will be recruited to this double-blind, placebo-controlled, randomized clinical trial with a parallel design. Eligible patients will be selected according to the inclusion criteria through a random sampling method, and will be randomly allocated to 10 weeks of synbiotic therapy or placebo. The primary outcome will be serum thyroid hormones including FT4 and TSH. Secondary outcomes will be systolic & diastolic blood pressure, depression, and quality of life. The data will be compared within and between groups using statistical methods via STATA software (version 14). This study will be conducted at Baqiyatallah hospital, Tehran, Iran.
Discussion: Preliminary studies indicate that synbiotic therapy may be a promising, tolerable, and cost-efficient therapy for lowering serum concentrations of thyroid hormones and complications of hypothyroidism. We hope the results of the present trial, positive or negative, will provide high quality proof-of-concept data to elucidate the possible efficacy of this innocuous nutritional therapy in hypothyroidism, and the results could be translated into clinical benefit.
Trial registration: The research is a registered clinical trial (Registration number: IRCT20210926052583N1, Iranian Registry of Clinical Trials (IRCT), registered October 11, 2019.
Keywords: Hypothyroidism; Prebiotic; Probiotic; Synbiotic; Thyroid hormones.
Copyright © 2022 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.