Gut microbiota influence the host immune system and are associated with various diseases. In recent years, postmenopausal bone loss has been suggested to be related to gut microbiota. In the present study, we investigated the treatment effect of the probiotic Bacillus subtilis C-3102 (C-3102) on bone mineral density (BMD) and its influence on gut microbiota in healthy postmenopausal Japanese women. Seventy-six healthy postmenopausal Japanese women were treated with a placebo or C-3102 spore-containing tablets for 24 weeks. When compared with the placebo, C-3102 significantly increased total hip BMD (placebo = 0.83 ± 0.63%, C-3102 = 2.53 ± 0.52%, p=0.043). There was a significant group-by-time interaction effect for urinary type I collagen cross-linked N-telopeptide (uNTx) (p=0.033), a marker of bone resorption. Specifically, the C-3102 group showed significantly lower uNTx when compared with the placebo group at 12 weeks of treatment (p=0.015). In addition, in the C-3102 group, there was a trend towards a decrease in the bone resorption marker tartrate-resistant acid phosphatase isoform 5b (TRACP-5b) when compared with the placebo group at 12 weeks of treatment (p=0.052). The relative abundance of genus Bifidobacterium significantly increased at 12 weeks of treatment compared with the baseline in the C-3102 group. The relative abundance of genus Fusobacterium was significantly decreased in the C-3102 group at 12 and 24 weeks of treatment compared with the baseline. These data suggested that C-3102 improves BMD by inhibiting bone resorption and modulating gut microbiota in healthy postmenopausal women.

This study investigated the effects of proanthocyanidins derived from Acacia (Acacia mearnsii) bark extract in healthy Japanese adult subjects experiencing uncomfortable skin symptoms. All subjects were randomly allocated into two groups (n = 33 each) using a computerized random-number generator. The subjects received either Acacia bark extract tablets or placebo for 8 weeks. Evaluations included water content in the stratum corneum, transepidermal water loss (TEWL), Skindex-16, dermatology life quality index (DLQI), visual analog scale for desire to scratch, and blood tests. At 4 weeks, the symptom/feeling score of DLQI, subjective symptoms related to uncomfortable skin, and the desire to scratch were significantly reduced in the intervention group than in the placebo group. At 8 weeks, the intervention group exhibited significantly lower TEWL on facial skin than that in the placebo group. In conclusion, the intake of Acacia bark extract tablets reduced TEWL and improved dry and uncomfortable skin.

Objective: Acacia bark-derived proanthocyanidins exhibit antioxidant, anti-inflammatory, anti-diabetic, hypotensive effects, and improving skin condition, in addition to beneficial effects on blood glucose. Herein, we evaluated the effects of acacia bark-derived proanthocyanidins on fasting and postprandial blood glucose levels in healthy Japanese adults with fasting blood glucose (FBG) levels between 110–125 mg/dL.Methods: Subjects were randomly allocated into 2 groups (n = 33 per group) and consumed 6 tablets/day of either tablets of acacia bark extract containing proanthocyanidins (Acacia group) or placebo for 12 weeks. Evaluation points were at the screening, and after 4-week (4w), 8-week (8w), and 12-week intervention (12w). The primary outcome was FBG level at 12 w, whereas the secondary outcomes were FBG level at 4w and 8w, the FBG changes from Scr to each-week intervention, the percentage of subjects with FBG levels below 110 mg/dL after 12 w, the measured value and the change value from Scr to each-week intervention of HbA1c, the measured value and the change value from Scr to each-week intervention of postprandial blood glucose levels.Results: A total of 33 subjects (18 men, 15 women) from each group were analyzed. The Acacia group had significantly lower FBG levels at 8 and 12 w than the placebo group (P = 0.030 and P = 0.014, respectively). The percentage of subjects with FBG <110 mg/dL at 12 w was marginally higher in the Acacia group than in the placebo group (P = 0.079). HbA1c at 12 w was significantly lowered in the Acacia group compared to the placebo group (P = 0.015).Conclusions: Acacia bark-derived proanthocyanidins were confirmed to have FBG-lowering effects.Trial registration: UMIN000039414Foundation: Acacia-No-Ki Co.,Ltd.Keywords: Acacia bark extract, Proanthocyanidins, Fasting blood glucose level, HbA1c

Background On the basis of phase III CheckMate 141 results, nivolumab was approved for recurrent or metastatic head and neck cancer after undergoing platinum-containing chemotherapy in Japan. This post-marketing surveillance aimed to evaluate the safety and effectiveness of nivolumab for head and neck cancer in the real-world setting. Methods All patients with head and neck cancer who planned to receive nivolumab were centrally registered. This study monitored 607 patients for 6 months to assess nivolumab’s safety, especially treatment-related adverse events (TRAEs) of special interest, and effectiveness. Results TRAEs occurred in 36.1% patients, with no new safety signals. The most common TRAEs with grade ≥ 3 were interstitial lung disease (1.2%), diarrhea (0.8%), and hepatic function abnormal (0.7%). Meanwhile, thyroid dysfunction (10.2%), hepatic dysfunction (5.3%), and interstitial lung disease (4.1%) were the most common TRAE categories of special interest. Although the median time to the onset of each TRAE category of special interest was mostly 1–2 months, most of them occurred throughout the observation period; nonetheless, the majority of patients recovered or remitted. The 6-month survival rate was 55.9%. Conclusion Japanese patients with head and neck cancer treated with nivolumab in the real-world setting manifested no new safety signals. Clinical Trial Registration clinicaltrials.jp: JapicCTI-184071.

Immune-related gastrointestinal toxicities (irGI) are well-known adverse events (AEs) with immune checkpoint inhibitors. The aim of this review was to present clinical data from 82 cases to provide information to clinicians who face real-world challenges among their patients with irGI AEs. The findings of this review support the use of the current management guidelines. By analyzing the treatment courses and outcomes of all cases identified, our review recommends that recurrent cases be treated carefully regardless of the grade of diarrhea at the onset of events. Earlier gastroenterology consultation and computed tomography/endoscopy diagnosis are essential, especially when an irGI AE recurs or worsens during steroid tapering. We would also suggest earlier decision to add immunosuppressant agents, particularly for recurrent cases.