Effects of excessive intake ofL. sIgA release 8 weeks after initiation of the study compared with baseline was significantly higher in the K71 tablet group (105. 5 119. 0 g/min) than in the placebo group (52. 7 62. 6 g/min; p=0. 047). There were no negative events associated with intake of tablets containing K71. The safety of intake ofL. paracaseiK71 was also verified in an impartial open-label trial with 20 healthy topics who consumed excessive amounts of K71-containing food. L. paracaseiK71 intake may therefore have some benefits in promoting mucosal immune function. Keywords: lactic acidity bacteria, Lactobacillus paracasei, secretory immunoglobulin A, immune function, clinical study == INTRO == Growing evidence suggests that lactic acidity bacteria may have potential health benefits [1, 2, 3]. Lactic acid bacteria are Gram-positive, anaerobic, or facultative aerobic cocci or rods that produce lactic acid as a major metabolite [4] and includeLactobacillus, Leuconostoc, Pediococcus, andStreptococcus. The health-benefiting actions of lactic acidity bacteria are species and strain specific [5]. Several species have been used as probiotics for more than 70 years [6], and their recognized beneficial activities include immune modulation [7] as well as anticancer [8] and hypocholesterolemic activities [5]. Regarding immune modulation, probiotic and commensal organisms have been shown to modulate the mucosal immune system through interaction with mucosal immune cells or epithelial cells [7]. Creature studies possess suggested that living and heat-killed lactobacilli can elicit an immune Clopidogrel response by binding to specific receptors on mucosal immune cells or epithelial cells to control cytokine/chemokine production, involving regulation of the function and generation of naive T cells, regulatory T cells, dendritic cells, and macrophages [7, 9, 10, 11]. Lactobacillus paracaseiK71 is an isolate from sake lees, sake being the traditional Japanese alcoholic beverage produced from polished rice [12]. We recently found that intake of a dietary supplement that contains heat-killedL. paracaseiK71 was effective in reducing the clinical severity of atopic dermatitis in a randomized controlled trial [13], suggesting that this bacterial strain had immunomodulatory activity. Furthermore, a preliminary clinical study suggested that intake ofL. paracaseiK71 enhanced secretory immunoglobulin A (sIgA) release in the saliva (unpublished observation). sIgA in the salivary glands is synthesized by plasma cells because dimeric IgA, constituting part of the first line of defense against pathogen invasion [14]. The level of salivary Clopidogrel sIgA release can reveal immune Clopidogrel function in the intraoral and upper respiratory tract [15], and salivary sIgA has been suggested as a potential measure of mucosal and systemic immunity [16, 17]. Based on these results, we conducted a double-blind randomized controlled trial to investigate the effects of intake of a dietary supplement that contains heat-killedL. paracaseiK71 on salivary sIgA release. In addition , an open-label trial of extreme consumption from the supplement was performed to confirm its security. == MATERIALS AND METHODS == == Test foods Keratin 7 antibody == The foods used in this study wereL. Clopidogrel paracaseiK71-containing tablets and placebo tablets (Kameda Seika Co., Ltd., Niigata, Japan). The compositions from the tablets are shown inTable 1 . The content ofL. paracaseiK71 was 100 mg (approximately 2 1011bacteria) per daily dose (0. 5 g; 2 tablets). In Trial 1 (efficacy examination), topics consumed two of the designated tablets once a day with water, tea, or coffee intended for 12 weeks. The dose ofL. paracaseiK71 was based on our initial investigation, which demonstrated that consuming 100 mg/day ofL. paracaseiK71 for 12 weeks enhanced the rate of salivary sIgA release. The daily dose of 100 mg ofL. paracaseiK71 was also shown to be effective in alleviating the clinical severity of atopic dermatitis [13]. In Trial 2 (safety examination under extreme consumption), topics consumed 1 . 5 g or 2 . 5 g of powdered formulation that.