Intestinal Research

Safety and effectiveness of budesonide rectal foam for ulcerative colitis in a large-scale, multicenter, prospective observational study: final report of post-marketing surveillance in Japan: Masayuki Saruta, Teppei Omori, Akira Nagaki, Yuki Arai, Minami Umeyama, Shinsuke Kurosu, Kiyotoshi Kuramoto, Yasuo Suzuki; Received July 31, 2025 Accepted November 13, 2025 Published online February 11, 2026; DOI: https://doi.org/10.5217/ir.2025.00164 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Budesonide rectal foam was approved in Japan in 2017 for mild to moderate active ulcerative colitis (UC). This is the final report of post-marketing surveillance to evaluate real-world safety and effectiveness.
Methods
This Japanese large-scale, prospective, multicenter, open-label observational study included patients with active-phase mild to moderate UC newly started on budesonide 2 mg rectal foam. Safety was evaluated by adverse drug reactions (ADRs). Effectiveness was evaluated using clinical remission rates and partial Mayo scores. Effectiveness by background (disease phenotype, severity, clinical course, age, prior topical therapy, baseline advanced therapy [biologicals/Janus kinase inhibitors]) was also assessed.
Results
There were 633 and 503 patients in the safety and effectiveness analyses, respectively. ADRs occurred in 4.3% (27/633) of patients. Eight glucocorticoid-related ADRs occurred in 7 patients (1.1%). Clinical remission rates were 44.2% (165/373), 72.1% (191/265), and 69.8% (333/477) at week 2, week 6, and the final evaluation, respectively. There were statistically significant changes from baseline in partial Mayo scores at all timepoints (all P< 0.0001 vs. baseline). At 2, 4, 6, and 6–12 weeks, mean± standard deviation changes from baseline in partial Mayo scores were −2.1 ± 1.9, −2.7 ± 2.1, −3.1 ± 2.3, and −3.4 ± 2.3 points, respectively. Statistically significant improvements were maintained at all timepoints in subgroup analyses by background (disease phenotype, severity, clinical course, age, prior topical therapy, baseline advanced therapy).
Conclusions
No new safety concerns were identified. Partial Mayo score improved in a variety of patient background factors. Health condition improvements were confirmed in this Japanese post-marketing surveillance. (Japan Registry of Clinical Trials, identifier jRCT1080223802)

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IBD

Lifestyle restrictions are associated with impaired quality of life but not reduction in relapse in ulcerative colitis: Hajime Yamazaki, Masakazu Nagahori, Tadakazu Hisamatsu, Taku Kobayashi, Teppei Omori, Jimmy K. Limdi, John T. McLaughlin, Shu-Chen Wei, Jovelle Fernandez, Shunichi Fukuhara, Katsuyoshi Matsuoka; Intest Res 2026;24(2):225-235. Published online May 14, 2025; DOI: https://doi.org/10.5217/ir.2024.00199

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Patients with ulcerative colitis (UC) in remission commonly restrict thir lifestyle to prevent relapse; however, the effectiveness and impact on quality of life (QOL) is unclear. This study investigated whether lifestyle restrictions are associated with relapse reduction and assessed their impact on QOL.
Methods
This multicenter, prospective cohort study was conducted in Japan (2018–2021) via the YOURS registry, enrolling patients with UC in clinical remission. Patients were followed for 2 years. A baseline questionnaire evaluated lifestyle restrictions in diet, work/study/housework, and physical exercise. QOL was assessed by Disease Impact Scale every 3 months during the first year of follow-up. Associations of lifestyle restrictions with relapse and QOL were assessed by Cox regression analysis and linear mixed-effects models, respectively.
Results
Among 911 patients in clinical remission for > 90 days, 63% had adopted dietary avoidance; 47%, work/study/housework avoidance; and 8%, physical exercise avoidance. Overall, 216 patients relapsed. Lifestyle restrictions were not associated with reduced risk of relapse (multivariableadjusted hazard ratios [95% confidence interval]: dietary avoidance, 1.08 [0.81–1.44]; and work/study/housework avoidance, 1.14 [0.87–1.50]); physical exercise avoidance was associated with increased relapse (multivariable-adjusted hazard ratio, 1.58; 95% confidence interval, 1.02–2.44). All lifestyle restrictions were associated with impaired QOL (P <0.01).
Conclusions
Lifestyle restrictions were not associated with relapse reduction in patients with UC; however, they were associated with impaired QOL. Clinicians should engage in evidence-based discussions with patients with UC in remission regarding lifestyle restrictions (UMIN Clinical Trials Registry; UMIN000031995).

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Can lifestyle restrictions prevent relapse in ulcerative colitis? A focus on quality of life
Jihye Park
Intestinal Research.2026; 24(2): 195. CrossRef
A nutrition- and exercise-based adjunct lifestyle program in active ulcerative colitis: pre–post improvements in quality of life and behavioral outcomes
Abdurrahim Yildiz, Ganime Kuşsan, Zehra Aksu, Dilan Çoban
Sport Sciences for Health.2026;[Epub] CrossRef

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IBD

Efficacy of serum leucine-rich alpha-2 glycoprotein in predicting findings of Crohn’s disease small bowel lesion in capsule endoscopy: Teppei Omori, Miki Koroku, Shun Murasugi, Ayumi Ito, Maria Yonezawa, Shinichi Nakamura, Katsutoshi Tokushige; Intest Res 2024;22(4):464-472. Published online May 7, 2024; DOI: https://doi.org/10.5217/ir.2023.00139

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Small bowel capsule endoscopy (SBCE) is an evaluation method for small bowel (SB) lesions in Crohn’s disease (CD). However, the relationship between SBCE findings and the serological biomarker leucine-rich alpha-2 glycoprotein (LRG) remains unclear. We aimed to establish appropriate cutoff values of LRG to predict the presence of SB lesions in CD through SBCE.
Methods
Patients with CD with SB lesions who had undergone SBCE and LRG measurements 1 month before and after the SBCE were included. The LRG values for ulcers ≥0.5 cm and other inflammatory lesions noted in SBCE were determined using the Youden Index, and the sensitivity and specificity were calculated. Additionally, the correlation between the SBCE scores (CD Activity in Capsule Endoscopy) and LRG values was evaluated.
Results
Forty patients without active colorectal lesions were included in the study. When the cutoff value of LRG for SB ulcers ≥ 0.5 cm was set at 14 μg/mL, the sensitivity was 92.3%, specificity was 81.5%, positive predictive value (PPV) was 70.6%, and negative predictive value (NPV) was 95.7%. In contrast, an LRG cutoff value of 12 μg/mL without inflammatory findings had a sensitivity of 91.7%, specificity of 82.1%, PPV of 68.8%, and NPV of 95.8%. CD Activity in Capsule Endoscopy correlated well with LRG values (Spearman’s rank correlation coefficient ρ = 0.681, P< 0.001).
Conclusions
An LRG cutoff value of 14 μg/mL may be useful in predicting the presence of SB ulcers ≥ 0.5 cm, and an LRG cutoff value of 12 μg/mL may be useful in predicting the absence of SB inflammatory findings.

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Capsule Endoscopy in Inflammatory Bowel Disease: Current Status and Issues in Clinical Practice
Teppei Omori, Haruka Wada, Tatsuya Mitsui, Mari Hayashida, Noritaka Hibi, Daisuke Saito, Tadakazu Hisamatsu
DEN Open.2026;[Epub] CrossRef
Leucine-rich alpha-2 glycoprotein as a blood biomarker in inflammatory bowel disease: clinical implications and future perspectives
Takayuki Yamamoto
Expert Review of Gastroenterology & Hepatology.2026; 20(2): 147. CrossRef
Leucine-rich alpha-2 glycoprotein as a superior biomarker to C-reactive protein for detecting small bowel lesions in Crohn’s disease
Masashi Ohno, Atsushi Nishida, Akinori Otsuki, Yoshihiro Yokota, Takayuki Imai, Shigeki Bamba, Osamu Inatomi
World Journal of Gastrointestinal Endoscopy.2025;[Epub] CrossRef
Complete mucosal healing prevents stricture progression after endoscopic balloon dilation in Crohn's disease
Jun Owada, Kunihiko Oguro, Tomonori Yano, Yusuke Ono, Takuma Kobayashi, Shoko Miyahara, Hirotsugu Sakamoto, Hironori Yamamoto
DEN Open.2025;[Epub] CrossRef

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IBD

Granulocyte and monocyte apheresis therapy for patients with active ulcerative colitis associated with COVID-19: a case report: Miki Koroku, Teppei Omori, Harutaka Kambayashi, Shun Murasugi, Tomoko Kuriyama, Yuichi Ikarashi, Maria Yonezawa, Ken Arimura, Kazunori Karasawa, Norio Hanafusa, Masatoshi Kawana, Katsutoshi Tokushige; Intest Res 2022;20(1):150-155. Published online March 12, 2021; DOI: https://doi.org/10.5217/ir.2020.00148

Abstract PDF PubReader ePub

Coronavirus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is now a pandemic. Although several treatment guidelines have been proposed for patients who have both inflammatory bowel disease and COVID-19, immunosuppressive therapy is essentially not recommended, and the treatment options are limited. Even in the COVID-19 pandemic, adjuvant adsorptive granulocyte and monocyte apheresis may safely bring ulcerative colitis (UC) into remission by removing activated myeloid cells without the use of immunosuppressive therapy. Our patient was a 25-year-old Japanese male with UC and COVID-19. This is the first case report of the induction of UC remission with granulocyte and monocyte apheresis treatment for active UC associated with COVID-19.

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Phenotypic changes in immune cells induced by granulocyte and monocyte adsorptive apheresis in patients with severe COVID‐19: An ex vivo study
Ryo Hisamune, Kazuma Yamakawa, Katsuhide Kayano, Noritaka Ushio, Takeshi Wada, Kohei Taniguchi, Akira Takasu
Acute Medicine & Surgery.2024;[Epub] CrossRef
SARS-CoV-2 vaccination for adult patients with inflammatory bowel disease: expert consensus statement by KASID
Yoo Jin Lee, Seong-Eun Kim, Yong Eun Park, Ji Young Chang, Hyun Joo Song, Duk Hwan Kim, Young Joo Yang, Byung Chang Kim, Jae Gon Lee, Hee Chan Yang, Miyoung Choi, Seung-Jae Myung
Intestinal Research.2022; 20(2): 171. CrossRef
SARS-CoV-2 Vaccination for Adult Patients with Inflammatory Bowel Disease: Expert Consensus Statements by KASID
Yoo Jin Lee, Seong-Eun Kim, Yong Eun Park, Ji Young Chang, Hyun Joo Song, Duk Hwan Kim, Young Joo Yang, Byung Chang Kim, Jae Gon Lee, Hee Chan Yang, Miyoung Choi, Seung-Jae Myung
The Korean Journal of Gastroenterology.2021; 78(2): 117. CrossRef

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