The effect of synbiotic supplementation on hypothyroidism: A randomized double-blind placebo controlled clinical trial

Abstract

Objective We hypothesize that synbiotic supplementation could modulate the intestinal microbiota and subsequently, improve the condition of hypothyroid patients. Methods Fifty-six adult hypothyroid patients were recruited to this double-blind, placebo-controlled, randomized clinical trial. The intervention was 10 weeks of synbiotic (500 mg of 109 CFU/g probiotics plus fructo-oligosaccharide, n = 28) compared to placebo (lactose, magnesium stearate, talc, and silicon dioxide, n = 28). Randomization and allocation to trial groups were carried out using random number sequences drawn from https://sealedenvelope.com/. Primary outcomes were serum thyroid stimulating hormone (TSH) and free thyroxine (FT4), and secondary outcomes were depression, quality of life, and blood pressure (BP). P-values< 0.05 were considered statistically significant. Results Analysis on 51 patients who completed the trial showed that TSH and depression (p> 0.05) did not change significantly, while serum FT4 significantly increased in both groups (p = 0.03 and p = 0.02 in symbiotic and placebo respectively). A significant decrease in systolic BP occurred only in the synbiotic group (p = 0.05). Significant improvements occurred regarding different domains and areas of quality of life in the crude and adjusted analysis, including perceived mental health (p = 0.02), bodily pain (p = 0.02), general health perception (p = 0.002), and wellbeing (p = 0.002), which were significantly higher in the synbiotic group. Conclusions Ten-week supplementation with synbiotic had no favorable effect on depression and TSH, but it improved blood pressure and quality of life in patients with hypothyroidism. More trials are needed to support or reject these findings. Trial registration IRCT20210926052583N1, Iranian Registry of Clinical Trials (IRCT), registered October 1st, 2021.

Lifestyle and Quality of Life of Women with Diagnosed Hypothyroidism in the Context of Metabolic Disorders

“…Majid Ramezani et al, who studied the effect of synbiotics on the course of hypothyroidism, reported an improvement in the quality of life of patients despite the lack of effect of supplementation with a product containing post-biotic bacteria on the concentration of TSH in plasma. Therefore, the supply of probiotic bacteria through the consumption of fermented products is recommended [46].…”

Protocol for a double-blinded randomised controlled trial to assess the effect of faecal microbiota transplantations on thyroid reserve in patients with subclinical autoimmune hypothyroidism in the Netherlands: the IMITHOT trial

“…Two recent studies observed a significant positive (but minimal clinical) effect of synbiotic supplementation on serum thyroid markers in patients with hypothyroidism using LT4 compared with their placebo-treated counterparts. Unfortunately, both studies lacked information on gut microbiota composition and functionality before and after the intervention 34 35. The present IMITHOT study is the first to test the effect of restoring intestinal homeostasis with healthy microbiota using faecal microbiota transplantations (FMTs) on thyroid function in medication-naïve patients with subclinical autoimmune hypothyroidism.…”

Assessment of the Impact of Nutritional Intervention with the Probiotic Lactiplantibacillus plantarum 299v on Nutritional Status and Quality of Life of Hashimoto’s Thyroiditis Patients—A Randomized Double-Blind Study Protocol

“…This blend showed no significant effect on anti-TPO [31]. Another study examined the effects of a synbiotic (500 mg of 10 9 CFU/g probiotics plus fructooligosaccharide) on adult hypothyroid patients [32]. Although a 10-week supplementation had no beneficial effects on serum thyroid-stimulating hormones, it did result in improved blood pressure and quality of life among patients with hypothyroidism [32].…”

“…Another study examined the effects of a synbiotic (500 mg of 10 9 CFU/g probiotics plus fructooligosaccharide) on adult hypothyroid patients [32]. Although a 10-week supplementation had no beneficial effects on serum thyroid-stimulating hormones, it did result in improved blood pressure and quality of life among patients with hypothyroidism [32]. Hashimoto's thyroiditis is characterized by an increased inflammatory burden, accompanied by increased red cell distribution width.…”