1.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
		                        		
		                        			 Background/Aims:
		                        			Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. 
		                        		
		                        			Methods:
		                        			This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.  
		                        		
		                        			Results:
		                        			Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.  
		                        		
		                        			Conclusions
		                        			The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed. 
		                        		
		                        		
		                        		
		                        	
2.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
		                        		
		                        			 Background/Aims:
		                        			Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. 
		                        		
		                        			Methods:
		                        			This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.  
		                        		
		                        			Results:
		                        			Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.  
		                        		
		                        			Conclusions
		                        			The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed. 
		                        		
		                        		
		                        		
		                        	
3.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
		                        		
		                        			 Background/Aims:
		                        			Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. 
		                        		
		                        			Methods:
		                        			This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.  
		                        		
		                        			Results:
		                        			Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.  
		                        		
		                        			Conclusions
		                        			The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed. 
		                        		
		                        		
		                        		
		                        	
4.Interleukin-34 cancels anti-tumor immunity by PARP inhibitor
Takayoshi NAKAMURA ; Nabeel KAJIHARA ; Naoki HAMA ; Takuto KOBAYASHI ; Ryo OTSUKA ; Nanumi HAN ; Haruka WADA ; Yoshinori HASEGAWA ; Nao SUZUKI ; Ken-ichiro SEINO
Journal of Gynecologic Oncology 2023;34(3):e25-
		                        		
		                        			 Objective:
		                        			Breast cancer susceptibility gene 1 (BRCA1)-associated ovarian cancer patients have been treated with A poly (ADP-ribose) polymerase (PARP) inhibitor, extending the progression-free survival; however, they finally acquire therapeutic resistance. Interleukin (IL)-34 has been reported as a poor prognostic factor in several cancers, including ovarian cancer, and it contributes to the therapeutic resistance of chemotherapies. IL-34 may affect the therapeutic effect of PARP inhibitor through the regulation of tumor microenvironment (TME). 
		                        		
		                        			Methods:
		                        			In this study, The Cancer Genome Atlas (TCGA) data set was used to evaluate the prognosis of IL-34 and human ovarian serous carcinoma. We also used CRISPR-Cas9 genome editing technology in a mouse model to evaluate the efficacy of PARP inhibitor therapy in the presence or absence of IL-34. 
		                        		
		                        			Results:
		                        			We found that IL34 was an independent poor prognostic factor in ovarian serous carcinoma, and its high expression significantly shortens overall survival. Furthermore, in BRCA1-associated ovarian cancer, PARP inhibitor therapy contributes to anti-tumor immunity via the XCR1+ DC-CD8+ T cell axis, however, it is canceled by the presence of IL-34. 
		                        		
		                        			Conclusion
		                        			These results suggest that tumor-derived IL-34 benefits tumors by creating an immunosuppressive TME and conferring PARP inhibitor therapeutic resistance. Thus, we showed the pathological effect of IL-34 and the need for it as a therapeutic target in ovarian cancer. 
		                        		
		                        		
		                        		
		                        	
5.Endoscopic Findings and Treatment of Gastric Neoplasms in Familial Adenomatous Polyposis
Chihiro SATO ; Kazuya TAKAHASHI ; Hiroki SATO ; Takumi NARUSE ; Nao NAKAJIMA ; Masafumi TAKATSUNA ; Ken-ichi MIZUNO ; Satoru HASHIMOTO ; Manabu TAKEUCHI ; Junji YOKOYAMA ; Masaaki KOBAYASHI ; Shuji TERAI
Journal of Gastric Cancer 2022;22(4):381-394
		                        		
		                        			 Purpose:
		                        			Gastric neoplasia is a common manifestation of familial adenomatous polyposis (FAP). This study aimed to elucidate the clinical characteristics, endoscopic features including fundic gland polyposis (FGPsis), and treatment outcomes of gastric neoplasms (GNs) in patients with FAP. 
		                        		
		                        			Materials and Methods:
		                        			A total of 35 patients diagnosed with FAP, including nine patients from four pedigrees who underwent esophagogastroduodenoscopy (EGD), were investigated regarding patient characteristics, GN morphology, and treatment outcomes. 
		                        		
		                        			Results:
		                        			Twenty-one patients (60.0%) had 38 GNs; 33 (86.8%) and 5 (13.2%) were histologically diagnosed with adenocarcinoma and adenoma, respectively. There were no specific patient characteristics related to GNs.Nodule-type GNs were more prevalent in patients with FGP than without (52.2% vs. 0.0%, P=0.002) in the upper body of the stomach. Conversely, depressed-type GNs were fewer in patients with FGPsis than in those without (13.0% vs. 73.3%, P<0.001). Slightly elevated-type GNs were observed in both groups (34.8% vs. 20.0%, P=0.538). Even within pedigrees, the background gastric mucosa and types of GNs varied. In total, 24 GNs were treated with endoscopic submucosal dissection (ESD) and eight with endoscopic mucosal resection (EMR). EMR was selected for GNs with FGPsis because of the technical difficulty of ESD, resulting in a lower en bloc resection rate (62.5% vs. 100%, P=0.014). 
		                        		
		                        			Conclusions
		                        			Our study indicates the necessity of routine EGD surveillance in patients diagnosed with FAP. Notably, the morphology and location of GNs differed between patients with and without FGPsis. Endoscopic treatment and outcomes require more attention in cases of FGPsis. 
		                        		
		                        		
		                        		
		                        	
6.Association Between the Cool Temperature-dependent Suppression of Colonic Peristalsis and Transient Receptor Potential Melastatin 8 Activation in Both a Randomized Clinical Trial and an Animal Model
Satoshi SUGINO ; Ken INOUE ; Reo KOBAYASHI ; Ryohei HIROSE ; Toshifumi DOI ; Akihito HARUSATO ; Osamu DOHI ; Naohisa YOSHIDA ; Kazuhiko UCHIYAMA ; Takeshi ISHIKAWA ; Tomohisa TAKAGI ; Hiroaki YASUDA ; Hideyuki KONISHI ; Yasuko HIRAI ; Katsura MIZUSHIMA ; Yuji NAITO ; Toshifumi TSUJI ; Takashi OKUDA ; Keizo KAGAWA ; Makoto TOMINAGA ; Yoshito ITOH
Journal of Neurogastroenterology and Motility 2022;28(4):693-705
		                        		
		                        			 Background/Aims:
		                        			Several studies have assessed the effect of cool temperature on colonic peristalsis. Transient receptor potential melastatin 8 (TRPM8) is a temperature-sensitive ion channel activated by mild cooling expressed in the colon. We examined the antispasmodic effect of cool temperature on colonic peristalsis in a prospective, randomized, single-blind trial and based on the video imaging and intraluminal pressure of the proximal colon in rats and TRPM8-deficient mice. 
		                        		
		                        			Methods:
		                        			In the clinical trial, we randomly assigned a total of 94 patients scheduled to undergo colonoscopy to 2 groups: the mildly cool water (n = 47) and control (n = 47) groups. We used 20 mL of 15°C water for the mildly cool water. The primary outcome was the proportion of subjects with improved peristalsis after treatment. In the rodent proximal colon, we evaluated the intraluminal pressure and performed video imaging of the rodent proximal colon with cool water administration into the colonic lumen. Clinical trial registry website (Trial No. UMIN-CTR; UMIN000030725). 
		                        		
		                        			Results:
		                        			In the randomized controlled trial, after treatment, the proportion of subjects with no peristalsis with cool water was significantly higher than that in the placebo group (44.7% vs 23.4%; P < 0.05). In the rodent colon model, cool temperature water was associated with a significant decrease in colonic peristalsis through its suppression of the ratio of peak frequency (P < 0.05). Cool temperaturetreated TRPM8-deficient mice did not show a reduction in colonic peristalsis compared with wild-type mice. 
		                        		
		                        			Conclusion
		                        			For the first time, this study demonstrates that cool temperature-dependent suppression of colonic peristalsis may be associated with TRPM8 activation. 
		                        		
		                        		
		                        		
		                        	
7.External validation of a clinical prediction rule on the need for radiologic imaging to identify urological disorders in adult patients with febrile urinary tract infections.
Ken-Ichiro KOBAYASHI ; Korei YAMASHITA ; Shinsuke MIZUNO ; Kenji KUBO ; Nobuhiro KOMIYA ; Satoko OTSU
Singapore medical journal 2022;63(3):167-169
8.CBCT imaging and histopathological characteristics of osteoradionecrosis and medicationrelated osteonecrosis of the jaw
Ichiro OGURA ; Yoshiyuki MINAMI ; Junya ONO ; Yoriaki KANRI ; Yasuo OKADA ; Kensuke IGARASHI ; Maiko HAGA-TSUJIMURA ; Ken NAKAHARA ; Eizaburo KOBAYASHI
Imaging Science in Dentistry 2021;51(1):73-80
		                        		
		                        			 Purpose:
		                        			The purpose of this study was to evaluate the cone-beam computed tomographic (CBCT) imaging and histopathological characteristics of osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ). 
		                        		
		                        			Materials and Methods:
		                        			Ten surgical specimens from segmental mandibulectomy (3 ORN and 7 MRONJ) were analyzed using CBCT. The CBCT parameters were as follows: high-resolution mode (tube voltage, 90.0 kV; tube current, 4.00 mA; rotation time, 16.8 s; field of view, 56 mm×56 mm; thickness, 0.099 mm). Histopathological characteristics were evaluated using histological slides of the surgical specimens. The Pearson chi-square test was used to compare ORN and MRONJ in terms of CBCT findings (internal texture, sequestrum, periosteal reaction and cortical perforation) and histopathological characteristics (necrotic bone, inflammatory cells, reactive bone formation, bacteria, Actinomyces, and osteoclasts). A P value less than 0.05 was considered to indicate statistical significance. 
		                        		
		                        			Results:
		                        			MRONJ showed periosteal reaction on CBCT more frequently than ORN (7 of 7 [100%] vs. 0 of 3 [0%], P<0.05). Regarding histopathological characteristics, MRONJ showed osteoclasts more frequently than ORN (6 of 7 [85.7%] vs. 0 of 3 [0%], P<0.05). 
		                        		
		                        			Conclusion
		                        			This study evaluated the CBCT imaging and histopathological characteristics of ORN and MRONJ, and the findings suggest that CBCT could be useful for the evaluation of ORN and MRONJ. 
		                        		
		                        		
		                        		
		                        	
9.The relationship of the Rohrer index and physical activity on motor function in upper elementary school children
Sota KOBAYASHI ; Satoshi HASEGAWA ; Masaki WATANABE ; Tadashi YANAGISAWA ; Ken TAKEHARA ; Shigeru USUDA
Japanese Journal of Physical Fitness and Sports Medicine 2021;70(2):181-188
		                        		
		                        			
		                        			The purpose of this study was to examine the relationship of the Rohrer index and physical activity on motor function. The subjects were 143 elementary school children in the 5th and 6th grades. Motor function was measured based on musculoskeletal examination. The Rohrer index was calculated from height and weight, and ≥140 was defined as a tendency to be overweight. Physical activity was investigated using a self-reported questionnaire, the WHO Health Behaviour in School-aged Children in Japanese version (HBSC-J). A total of 130 students and their parents agreed to participate in this study, and the data of 127 students were analyzed. The main results were as follows: 26 students had a Rohrer index ≥140, and 60 students (47.2%) had abnormalities in one or more items of motor function. In particular, there were many who reported “Impossible to fully squat” and “Limitation of standing forward flexion”. When compared by sex, “Impossible to fully squat”, “Limitation of standing forward flexion”, and “Pain in shoulder” were particularly frequent in boys. The Rohrer index was particularly high in those who reported that it was “Impossible to fully squat”, but it was not associated with HBSC-J. “Impossible to fully squat” was particularly low in HBSC-J (days of Moderate to vigorous Physical Activity and frequency of Vigorous Physical Activity). The results suggested that children of impossible to fully squat is a lot of low activity and obesity. In conclusion, children who are unable to squat should be followed up to promote physical activity and improve obesity.
		                        		
		                        		
		                        		
		                        	
            

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