Spaggiari Giorgia, Brigante Giulia, De Vincentis Sara, Cattini Umberto, Roli Laura, De Santis Maria Cristina, Baraldi Enrica, Tagliavini Simonetta, Varani Manuela, Trenti Tommaso, Rochira Vincenzo, Simoni Manuela, Santi Daniele
Unit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Unit of Endocrinology, Department of Medicine, Endocrinology, Metabolism and Geriatrics, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.
Front Endocrinol (Lausanne). 2017 Nov 14;8:316. doi: 10.3389/fendo.2017.00316. eCollection 2017.
The relationship between probiotics and levothyroxine (LT) requirement has not yet been investigated. The aim of this study was to assess whether a mixture of highly charged and (VSL#3) is able to influence LT metabolism acting on the gut microbiota.
A prospective, randomized, single-blind, controlled, investigator-started clinical trial was carried out. Patients with primary hypothyroidism were randomly assigned to the study (VSL#3 + LT) and the control group (LT). A 2-month treatment phase was followed by 2 months of follow-up. Clinical examination, blood tests for thyroid function and for peripheral tissue markers of thyroid hormones (PTM) were performed monthly. LT dose adjustments were performed when necessary.
Thirty-nine patients were enrolled in the study group and 41 in the control group. No difference in thyroid function [thyroid-stimulating hormone (TSH), free triiodothyronine (fT), and free thyroxine (fT)] and PTM was found between groups and among visits. FT/fT ratio was directly correlated to TSH at each visit in both groups, with the exception of the first evaluation of probiotics-treated subjects (rho = 0.287, = 0.076). LT daily dose adjustments occurred more frequently in the control than in the study group ( = 0.007), despite no differences in the mean LT daily dose. In particular, LT doses were increased six times in the control group and decreased four times in the study group.
VSL#3 does not directly alter thyroid functional compensation. A probiotics-mediated influence on thyroid hormones homeostasis is suggested since probiotics supplementation could be able to prevent serum hormonal fluctuations.
Registration number NCT03095963.
益生菌与左甲状腺素（LT）需求量之间的关系尚未得到研究。本研究的目的是评估高电荷益生菌混合物（VSL#3）是否能够通过作用于肠道微生物群来影响LT代谢。
开展了一项前瞻性、随机、单盲、对照、研究者发起的临床试验。原发性甲状腺功能减退患者被随机分配至研究组（VSL#3 + LT）和对照组（LT）。2个月的治疗阶段之后是2个月的随访期。每月进行临床检查、甲状腺功能血液检测以及甲状腺激素外周组织标志物（PTM）检测。必要时进行LT剂量调整。
研究组纳入39例患者，对照组纳入41例患者。两组之间以及各次访视之间，甲状腺功能[促甲状腺激素（TSH）、游离三碘甲状腺原氨酸（fT）和游离甲状腺素（fT）]和PTM均无差异。两组中每次访视时FT/fT比值均与TSH直接相关，但益生菌治疗受试者的首次评估除外（rho = 0.287，P = 0.07）。尽管平均每日LT剂量无差异，但对照组LT每日剂量调整比研究组更频繁（P = 0.007）。具体而言，对照组LT剂量增加6次，研究组减少4次。
VSL#3不会直接改变甲状腺功能代偿。由于补充益生菌可能能够预防血清激素波动，提示益生菌对甲状腺激素稳态有介导作用。
NCT03095963。
