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.

Abstract

The current treatment for the autoimmune disease of hypothyroidism (AIDH) is based on pharmacotherapy with levothyroxine. A non-pharmacological supplementary element of therapy could be the implementation of an individualized balanced diet and probiotics. Lactiplantibacillus plantarum 299v (Lp299v), with its anti-inflammatory effects, may also support the therapy. However, the number of studies on personalized dietary interventions with probiotics in AIDH is limited, and no clear conclusions can be drawn from the results so far. Therefore, this trial will analyze the effect of Lp299v supplementation in conjunction with nutrition education on the quality of life and nutritional status of patients with Hashimoto's. Methods: This double-blind, 12-week intervention study will include 100 female patients with AIDH. They will be divided into two groups: (1) individual personalized nutrition education + Lp299v and (2) individual personalized nutrition education + placebo. Before and after the education intervention, selected elements in the diet, eating behavior, quality of life, nutritional status (anthropometric parameters, body composition), blood pressure, and anti-TPO (antibodies against thyroid peroxidase) titer will be assessed. Hypothesis: It is expected that this study will provide deeper knowledge on the validity of using proper nutritional principles and Lp299v in AIDH. Specifically, the impact on the subjective assessment of the quality of life, selected elements in the diet, and the state of nutrition and health will be assessed.