Intestinal Research

Original Articles

Efficacy and safety of mirikizumab in maintenance therapy for ulcerative colitis in difficult-to-treat inflammatory bowel disease: a single-center retrospective study in Japan: Ichiro Mizushima, Yusuke Yoshimatsu, Hiroki Kiyohara, Shinya Sugimoto, Tomohisa Sujino, Kaoru Takabayashi, Yohei Mikami, Takanori Kanai; Received August 13, 2025 Accepted November 19, 2025 Published online February 11, 2026; DOI: https://doi.org/10.5217/ir.2025.00176 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Randomized controlled trials have confirmed the efficacy and safety of mirikizumab, an anti-interleukin-23p19 monoclonal antibody, for moderate-to-severe active ulcerative colitis (UC). However, there are no real-world data on the efficacy and safety of mirikizumab for UC as maintenance therapy, especially in difficult-to-treat inflammatory bowel disease (DTT-IBD). This study aimed to evaluate the long-term efficacy and safety of mirikizumab in patients with UC of DTT-IBD.
Methods
This was a single-center retrospective observational study involving adult patients with UC who received mirikizumab between January 2023 and April 2025 and met the criteria for DTT-IBD (e.g., failure of biologics and advanced small molecule drugs with at least 2 different mechanisms of action). The primary outcome was the clinical response at week 52. Secondary outcomes included steroid-free clinical remission within 52 weeks and the persistency of mirikizumab use. Adverse events were also recorded.
Results
Thirty-two patients were included in this study. The median 2-item patient-reported outcome score at baseline was 3 (interquartile range, 2–4). The proportion of patients with a clinical response at week 52 was 33.3% (95% confidence interval, 14.6%–57.0%). Steroid-free clinical remission was achieved in 26.7% (95% confidence interval, 12.3%–45.9%) of the patients. The cumulative continuous rate of mirikizumab use at week 52 was approximately 60%. Only 1 patient developed a serious adverse event requiring hospitalization (pneumonia), and mirikizumab was successfully resumed after recovery.
Conclusions
The present study demonstrated real-world data regarding maintenance therapy with mirikizumab for UC among patients with DTT-IBD.

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IBD

Ulcerative colitis-associated neoplasms often harbor poor prognostic histologic components with low detection by biopsy: Ryoya Sakakibara, Shinya Sugimoto, Kaoru Takabayashi, Hiroki Kiyohara, Yusuke Wakisaka, Yuta Kaieda, Miho Kawaida, Yusuke Yoshimatsu, Tomohisa Sujino, Naoki Hosoe, Motohiko Kato, Masayuki Shimoda, Yohei Mikami, Yasushi Iwao, Takanori Kanai; Intest Res 2024;22(4):428-438. Published online May 7, 2024; DOI: https://doi.org/10.5217/ir.2024.00006

Abstract PDF PubReader ePub

Background/Aims
Poorly differentiated adenocarcinoma, signet-ring cell carcinoma, and mucinous adenocarcinoma (por/sig/muc), which are considered to be histologic subtypes with a poor prognosis, occur more frequently with colitis-associated cancer than with sporadic tumors. However, their invasiveness and manifestations are unclear. This study aimed to determine the prevalence of the por/sig/muc component in ulcerative colitis-associated neoplasms (UCANs) and its association with invasiveness and to clarify its clinicohistologic and endoscopic features.
Methods
This retrospective observational study included patients diagnosed with ulcerative colitis-associated high-grade dysplasia or adenocarcinoma from 1997 to 2022 who were divided according to the presence or absence of a por/sig/muc component.
Results
Thirty-five patients had UCAN with a por/sig/muc component and 66 had UCAN without this component. The 5-year survival rate was significantly lower in the por/sig/muc group than in the tub group (67% vs. 96%, P= 0.001), which was attributed to disease above stage III and depth to below the subserosa. Biopsy-based diagnosis before resection detected a por/sig/muc component in only 40% of lesions (14/35). Lesions with a por/sig/muc component were prevalent even in the early stages: stage 0 (4/36, 11%), I (8/20, 40%), II (7/12, 58%), III (10/14, 71%), and IV (6/8, 75%).
Conclusions
This is the first investigation that shows UCANs with a por/sig/muc component tended to be deeply invasive and were often not recognized preoperatively. Endoscopists should be aware that UCAN often has a por/sig/muc component that is not always recognized on biopsy, and the optimal treatment strategy needs to be carefully considered.

Citations

Citations to this article as recorded by

Underestimation of the horizontal extent of ulcerative colitis-associated neoplasia may lead to incomplete endoscopic resection and subsequent recurrence
Soichiro Murakami, Shinya Sugimoto, Yasushi Iwao, Kaoru Takabayashi, Hiroki Kiyohara, Yusuke Yoshimatsu, Ryoya Sakakibara, Yuta Kaieda, Arina Shigehara, Naoki Hosoe, Motohiko Kato, Yohei Mikami, Takanori Kanai
Therapeutic Advances in Gastroenterology.2026;[Epub] CrossRef
Adjustment of Surveillance Intervals for Ulcerative Colitis‐Associated Neoplasia Based on Disease Duration
Ryoya Sakakibara, Shinya Sugimoto, Yuta Kaieda, Hiroki Kiyohara, Yusuke Yoshimatsu, Kaoru Takabayashi, Soichiro Murakami, Miho Kawaida, Tomohisa Sujino, Naoki Hosoe, Motohiko Kato, Yasushi Iwao, Yohei Mikami, Takanori Kanai
Digestive Endoscopy.2025; 37(10): 1068. CrossRef
Characterization of Computed Tomography Colonography Findings of Ulcerative Colitis-Associated Neoplasia
Yuta Kaieda, Shinya Sugimoto, Tatsuya Suzuki, Shunsuke Matsumoto, Hiroki Kiyohara, Kaoru Takabayashi, Yusuke Yoshimatsu, Koji Okabayashi, Kohei Shigeta, Ryoya Sakakibara, Yusuke Wakisaka, Soichiro Murakami, Masahiro Jinzaki, Yasushi Iwao, Yohei Mikami, Ta
Inflammatory Bowel Diseases.2025;[Epub] CrossRef

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272 Download
3 Web of Science
3 Crossref

IBD

Risk of venous thromboembolism with a central venous catheter in hospitalized Japanese patients with inflammatory bowel disease: a propensity score-matched cohort study: Yasuhiro Aoki, Hiroki Kiyohara, Yohei Mikami, Kosaku Nanki, Takaaki Kawaguchi, Yusuke Yoshimatsu, Shinya Sugimoto, Tomohisa Sujino, Kaoru Takabayashi, Naoki Hosoe, Haruhiko Ogata, Yasushi Iwao, Takanori Kanai; Intest Res 2023;21(3):318-327. Published online February 10, 2023; DOI: https://doi.org/10.5217/ir.2022.00116

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Thromboprophylaxis is recommended for hospitalized patients with inflammatory bowel disease (IBD) in Western countries, although it is selectively administered to high-risk patients in East Asia. A central venous catheter (CVC) is commonly placed in patients with IBD. Although CVC placement is considered a risk factor for venous thromboembolism (VTE), the degree of increased risk in patients with IBD is uncertain. This study aimed to identify the risk of VTE with CVC placement in hospitalized Japanese patients with IBD without thromboprophylaxis.
Methods
This retrospective cohort study included patients with ulcerative colitis or Crohn’s disease who were admitted for disease flares at Keio University Hospital between January 2016 and December 2020. Patients who already had thrombosis or were administered any antithrombotic treatment on admission were excluded. VTE development during the hospitalization was surveyed, and VTE risk associated with CVC indwelling was estimated using propensity score matching and inverse probability of treatment weighting analyses.
Results
Altogether, 497 hospitalized patients with IBD (ulcerative colitis, 327; Crohn’s disease, 170) were enrolled. VTE developed in 9.30% (12/129) of catheterized patients and in 0.82% (3/368) of non-catheterized patients. The propensity score matching yielded 127 matched pairs of patients. The catheterized group demonstrated higher odds for VTE than the non-catheterized group (odds ratio, 13.15; 95% confidence interval, 1.68–102.70). A similar result was obtained in the inverse probability of treatment weighting analysis (odds ratio, 11.02; 95% confidence interval, 2.64–46.10).
Conclusions
CVC placement is a major risk factor for VTE among hospitalized Japanese patients with IBD without thromboprophylaxis.

Citations

Citations to this article as recorded by

Incidence of Venous Thromboembolism in Asian Patients With Inflammatory Bowel Disease: A Systematic Review and Meta‐Analysis
Joo Hye Song, Sung Ryul Shim, Dae Sung Kim, Hoon Sup Koo, Kyu Chan Huh
Journal of Gastroenterology and Hepatology.2025; 40(4): 774. CrossRef
Metabolic Disorders and Inflammatory Bowel Diseases
Hye Kyung Hyun, Jae Hee Cheon
Gut and Liver.2025; 19(3): 307. CrossRef
Coagulopathy and platelet abnormalities in patients with inflammatory bowel disease
Dae Sung Kim, Won Moon
The Korean Journal of Internal Medicine.2025; 40(6): 866. CrossRef
Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study
Hyuk Yoon, Byong Duk Ye, Sang-Bum Kang, Kang-Moon Lee, Chang Hwan Choi, Joo-young Jo, Juwon Woo, Jae Hee Cheon
BMC Gastroenterology.2024;[Epub] CrossRef

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Case Report

IBD

Fecal microbiota transplantation for recurrent Clostridium difficile infection in a patient with ulcerative colitis: Kosaku Nanki, Shinta Mizuno, Katsuyoshi Matsuoka, Keiko Ono, Shinya Sugimoto, Hiroki Kiyohara, Mari Arai, Moeko Nakashima, Kozue Takeshita, Keiichiro Saigusa, Mitsutoshi Senoh, Tadashi Fukuda, Makoto Naganuma, Haru Kato, Wataru Suda, Masahira Hattori, Takanori Kanai; Intest Res 2018;16(1):142-146. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.142

Abstract PDF PubReader ePub

Fecal microbiota transplantation (FMT) has been reported as a safe and effective therapy in patients with refractory and recurrent Clostridium difficile infection (CDI). FMT has also been reported as a promising therapy in patients with ulcerative colitis (UC). Both, CDI and UC, are believed to be caused by dysbiosis, such as altered compositions or decreased diversity of the intestinal microbiota. This report describes a patient with UC in remission with a second recurrent episode of CDI, who was treated with FMT. A single FMT performed via colonoscopy completely resolved the patient's diarrhea and eradicated C. difficile bacteriologically without any severe complications. Molecular biological analysis of the patient's fecal microbiota showed that FMT could dramatically change the altered composition of intestinal microbiota and restore its diversity. Despite the restoration of the intestinal microbiota, FMT could not prevent a relapse of UC in this patient. However, it improved the intestinal symptoms of CDI and could prevent further recurrences of CDI.

Citations

Citations to this article as recorded by

Infección por Clostridioides difficile: Documento de posicionamiento de la Societat Catalana de Digestologia
Clàudia Aràjol, Begoña González Suárez, María Bonilla Moreno, Mireia Puig-Asensio, Virginia Robles-Alonso, Gerard Surís, Cristina Solé, José Ramón Santos, Lorena Rodríguez-Alonso
Gastroenterología y Hepatología.2026; : 502634. CrossRef
Impact of Clostridioides difficile Infection on Clinical Outcomes in Hospitalized IBD Patients and the Role of Fecal Microbiota Transplantation: A Retrospective Cohort Study
Puo‐Hsien Le, Chyi‐Liang Chen, Chia‐Jung Kuo, Pai‐Jui Yeh, Chien‐Chang Chen, Yi‐Ching Chen, Cheng‐Tang Chiu, Hao‐Tsai Cheng, Yung‐Kuan Tsou, Yu‐Bin Pan, Cheng‐Hsun Chiu
The Kaohsiung Journal of Medical Sciences.2025;[Epub] CrossRef
Intestinal Microbiota and Fecal Transplantation in Patients with Inflammatory Bowel Disease and Clostridioides difficile: An Updated Literature Review
Chloe Lahoud, Toni Habib, Daniel Kalta, Reem Dimachkie, Suzanne El Sayegh, Liliane Deeb
Journal of Clinical Medicine.2025; 14(15): 5260. CrossRef
Comparative Efficacy of Fecal Microbiota Transplantation in Treating Refractory or Recurrent Clostridioides difficile Infection among Patients with and without Inflammatory Bowel Disease: A Retrospective Cohort Study
Jing-Han Chen, Cheng-Hsun Chiu, Chien-Chang Chen, Yi-Ching Chen, Pai-Jui Yeh, Chia-Jung Kuo, Cheng-Tang Chiu, Hao-Tsai Cheng, Yu-Bin Pan, Puo-Hsien Le
Biomedicines.2024; 12(7): 1396. CrossRef
Case report: Fecal microbiota transplant for Clostridium difficile infection in a pregnant patient with acute severe ulcerative colitis
Hanyu Wang, Feihong Deng, Min Luo, Xuehong Wang
Frontiers in Immunology.2024;[Epub] CrossRef
The first international Rome consensus conference on gut microbiota and faecal microbiota transplantation in inflammatory bowel disease
Loris Riccardo Lopetuso, Sara Deleu, Lihi Godny, Valentina Petito, Pierluigi Puca, Federica Facciotti, Harry Sokol, Gianluca Ianiro, Luca Masucci, Maria Abreu, Iris Dotan, Samuel Paul Costello, Ailsa Hart, Tariq H Iqbal, Sudarshan Paramsothy, Maurizio San
Gut.2023; 72(9): 1642. CrossRef
Fecal microbiota transplantation as therapy for recurrent Clostridioides difficile infection is associated with amelioration of delirium and accompanied by changes in fecal microbiota and the metabolome
Kazuyoshi Gotoh, Yoshihiko Sakaguchi, Haru Kato, Hayato Osaki, Yasutaka Jodai, Mitsutaka Wakuda, Akira Také, Shunji Hayashi, Eri Morita, Takehiko Sugie, Yoichiro Ito, Naoki Ohmiya
Anaerobe.2022; 73: 102502. CrossRef
Management of Clostridioides difficile infection in patients with inflammatory bowel disease
Sahil Khanna
Intestinal Research.2021; 19(3): 265. CrossRef
Gut microbiota in ulcerative colitis: insights on pathogenesis and treatment
Xiao Yan Guo, Xin Juan Liu, Jian Yu Hao
Journal of Digestive Diseases.2020; 21(3): 147. CrossRef
RecurrentClostridium difficileInfection: Risk Factors, Treatment, and Prevention
Jung Hoon Song, You Sun Kim
Gut and Liver.2019; 13(1): 16. CrossRef
Current Status of Clostridium Difficile Infection
Akira Andoh, Shigeki Bamba
Nippon Daicho Komonbyo Gakkai Zasshi.2018; 71(10): 456. CrossRef

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Original Article

Single fecal microbiota transplantation failed to change intestinal microbiota and had limited effectiveness against ulcerative colitis in Japanese patients: Shinta Mizuno, Kosaku Nanki, Katsuyoshi Matsuoka, Keiichiro Saigusa, Keiko Ono, Mari Arai, Shinya Sugimoto, Hiroki Kiyohara, Moeko Nakashima, Kozue Takeshita, Makoto Naganuma, Wataru Suda, Masahira Hattori, Takanori Kanai; Intest Res 2017;15(1):68-74. Published online January 31, 2017; DOI: https://doi.org/10.5217/ir.2017.15.1.68

Abstract PDF Supplementary Material PubReader ePub

<b>Background/Aims</b><br/>

Recent developments in analytical techniques including next-generation sequencing have clarified the correlation between intestinal microbiota and inflammatory bowel disease. Fecal microbiota transplantation (FMT) for patients with ulcerative colitis (UC) is proposed as a potential approach to resolving their dysbiosis; however, its safety and efficacy have not been confirmed. This single-arm, open-label, non-randomized study aimed to evaluate the safety and efficacy of FMT for Japanese patients with UC as the first registered clinical trial in Japan.

Methods

We enrolled 10 patients with active UC despite medical therapy. The donors were the patients' relatives and were carefully screened for infectious diseases. Fecal material was administered via colonoscopy, and the primary endpoint was the presence or absence of serious adverse events related to FMT. The secondary endpoint was a change in partial Mayo score at 12 weeks post-FMT. Scores ≤2 were considered a clinical response. Fecal samples were collected to follow changes in gut microbiota, while extracted complementary DNA were analyzed by a next-generation sequencer. We obtained written informed consent from all patients and donors. This study was approved by our Institutional Review Board and is registered in the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN 000012814).

Results

Five patients with moderate disease and five with severe disease were enrolled. No severe adverse effects were observed. One patient achieved clinical response; however, none of the patients' microbiota diversity recovered to the donor levels.

Conclusions

The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.

Citations

Citations to this article as recorded by

Towards an Asian paradigm of inflammatory bowel disease management: A comparative review of China and Japan
Qi Sun, Zhixian Jiang, Lichao Yang, Hao Liu, Peipei Song, Lianwen Yuan
Intractable & Rare Diseases Research.2025; 14(3): 192. CrossRef
Gut microbiota–cholesterol crosstalk in cardiovascular diseases: mechanisms, metabolites, and therapeutic modulation
Mohammad Abavisani, Seyed Mohammad Sajjadi, Negar Ebadpour, Sercan Karav, Amirhossein Sahebkar
Nutrition & Metabolism.2025;[Epub] CrossRef
Single-Donor and Pooling Strategies for Fecal Microbiota Transfer Product Preparation in Ulcerative Colitis: A Systematic Review and Meta-analysis
Benoît Levast, Mathieu Fontaine, Stéphane Nancey, Pierre Dechelotte, Joël Doré, Philippe Lehert
Clinical and Translational Gastroenterology.2023; 14(5): e00568. CrossRef
Recipient-independent, high-accuracy FMT-response prediction and optimization in mice and humans
Oshrit Shtossel, Sondra Turjeman, Alona Riumin, Michael R. Goldberg, Arnon Elizur, Yarin Bekor, Hadar Mor, Omry Koren, Yoram Louzoun
Microbiome.2023;[Epub] CrossRef
Transfer of FRozen Encapsulated multi-donor Stool filtrate for active ulcerative Colitis (FRESCO): study protocol for a prospective, multicenter, double-blind, randomized, controlled trial
Andreas Stallmach, Philip Grunert, Johannes Stallhofer, Bettina Löffler, Michael Baier, Jürgen Rödel, Michael Kiehntopf, Sophie Neugebauer, Dietmar H. Pieper, Howard Junca, Andrea Tannapfel, Ute Merkel, Ulrike Schumacher, Maria Breternitz-Gruhne, Tabitha
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An updated systematic review and meta-analysis of fecal microbiota transplantation for the treatment of ulcerative colitis
Taobi Huang, Jinlan Xu, Maoying Wang, Ke Pu, Longquan Li, Huiyun Zhang, Yuan Liang, Weiming Sun, Yuping Wang
Medicine.2022; 101(30): e29790. CrossRef
Hot topics on fecal microbiota transplantation for the treatment of inflammatory bowel disease
Xiaochen Zhang, Dai Ishikawa, Toshifumi Ohkusa, Shinji Fukuda, Akihito Nagahara
Frontiers in Medicine.2022;[Epub] CrossRef
The Effects of Multi-Donor Fecal Microbiota Transplantation Capsules Combined with Thalidomide on Hormone-Dependent Ulcerative Colitis
Xiao-He Guo, Yan-Li Zhu, Lu Yang, Wen-Jing Li, Xue-Fang Du
Infection and Drug Resistance.2022; Volume 15: 7495. CrossRef
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Immunological Medicine.2021; 44(1): 30. CrossRef
Bacteriotherapy for inflammatory bowel disease
Yusuke Yoshimatsu, Yohei Mikami, Takanori Kanai
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Repeated Fecal Microbial Transplantations and Antibiotic Pre-Treatment Are Linked to Improved Clinical Response and Remission in Inflammatory Bowel Disease: A Systematic Review and Pooled Proportion Meta-Analysis
Valentin Mocanu, Sabitha Rajaruban, Jerry Dang, Janice Y. Kung, Edward C. Deehan, Karen L. Madsen
Journal of Clinical Medicine.2021; 10(5): 959. CrossRef
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Tadashi Ohara
Archives of Pathology and Clinical Research.2021; 5(1): 004. CrossRef
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Ivana Cibulková, Veronika Řehořová, Jan Hajer, František Duška
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Herbert L. DuPont, Zhi-Dong Jiang, Andrew W. DuPont, Netanya S. Utay
Digestive Diseases and Sciences.2020; 65(3): 741. CrossRef
Gut microbiota in ulcerative colitis: insights on pathogenesis and treatment
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Luciane de Fátima Caldeira, Helena H. Borba, Fernanda S. Tonin, Astrid Wiens, Fernando Fernandez-Llimos, Roberto Pontarolo, Udai P. Singh
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RecurrentClostridium difficileInfection: Risk Factors, Treatment, and Prevention
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