Microbial fermentative capacity of individuals with ulcerative colitis with an ileoanal pouch compared to a healthy or ulcerative colitis with intact colons: an in vitro study

Start Date30 Jul 2024

Sponsor / Collaborator

Monash University

NCT06316999 / RecruitingNot ApplicableIIT

Utility of Intestinal Ultrasound as a Diagnostic Tool for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis: A Prospective Pilot Study

Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).

Start Date01 Jul 2024

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Ileitis

100 Translational Medicine associated with Ileitis

0 Patents (Medical) associated with Ileitis

3,946

Literatures (Medical) associated with Ileitis

01 Apr 2025·DEN Open

Duodenitis associated with ulcerative colitis and pouchitis after total colectomy successfully treated with upadacitinib: A case report

Article

Author: Shimizu, Masahito ; Kojima, Kentaro ; Onishi, Sachiyo ; Kubota, Masaya ; Takada, Jun ; Otani, Kiichi ; Ibuka, Takashi ; Tezuka, Yukari ; Masuda, Naoya

AbstractA 27‐year‐old man had ulcerative colitis (UC) 1 year prior and underwent a colectomy and two‐stage ileal pouch‐anal anastomosis for medically refractory UC 6 months ago. He visited our department with epigastric pain and discomfort, increased stool frequency, and bloody diarrhea. Esophagogastroduodenoscopy revealed continuous diffuse friable mucosa, erosions, and edema in the duodenum, and pouchoscopy revealed multiple ulcers and purulent mucus adhesions. Based on endoscopic and pathological findings, the patient was diagnosed with duodenitis associated with UC and pouchitis, for which he received oral prednisolone (40 mg/day) and ciprofloxacin. The frequency of stools and occurrence of bloody diarrhea reduced, and epigastric pain and discomfort improved after 2 weeks. However, when prednisolone was discontinued, the symptoms worsened, albumin level decreased, and C‐reactive protein level increased. Following this, we administered a 20 mg prednisolone sodium phosphate enema once daily, and the patient's symptoms improved. However, the symptoms relapsed when the enema was discontinued. Assuming that the patient had steroid‐dependent duodenitis associated with UC and pouchitis, we initiated upadacitinib. His symptoms improved within a few days, and biomarkers returned to normal after 1 month. Nine months after initiating the upadacitinib treatment, endoscopic remission was achieved in the mucosa of the duodenum and pouch. The patient has been in clinical remission for 1 year without any adverse events.

01 Apr 2025·DEN Open

Endoscopic assessment of the J pouch in ulcerative colitis: A narrative review

Review

Author: Shiroyama, Mamiko ; Ito, Yuka ; Onoda, Tsubasa ; Rubin, David T ; Tsuchiya, Kiichiro ; Barnes, Edward L ; Akiyama, Shintaro ; Ishikawa, Naoki

AbstractPatients with ulcerative colitis sometimes need a total colectomy with ileal pouch‐anal anastomosis due to medically refractory disease or colitis‐associated neoplasia. Up to 50% of patients with ulcerative colitis postoperatively develop pouchitis and the rate of chronic inflammatory pouch conditions requiring pouch excision or diverting ileostomy is reported to be 10%. In order to diagnose and monitor pouchitis, pouchoscopy is essential to assess endoscopic inflammatory findings of the J pouch and to survey neoplasia development, particularly in the remnant distal rectum. However, endoscopic protocols for the evaluation of the pouch may not be standardized worldwide and the reliability of existing disease activity indices for pouchitis has been questioned due to the lack of validation. Recently, reliable endoscopic scoring systems based on an observation of the anatomical location of the J pouch were reported and a significant association between the distribution pattern of endoscopic inflammation (i.e., endoscopic phenotype) and pouch outcomes was also uncovered. In this review, we discuss how to survey the J pouch using pouchoscopy, endoscopic indices for pouchitis disease activity, endoscopic phenotypes and classification, and the pathological mechanisms of pouchitis phenotype in patients with ulcerative colitis.

01 Jan 2025·International Journal of Food Microbiology

Novel insights into biofilm formation and the key differentially expressed genes in Yersinia enterocolitica from meat: Implications for food safety and disease prevention

Article

Author: Wu, Yue ; Chen, Zongzong ; Xiao, Xiao ; Fang, Zhiguo ; Lou, Xiuqin ; Zhang, Qian

Yersinia enterocolitica is an important foodborne pathogen that can cause a zoonotic disease known as yersiniosis, which causes symptoms such as acute diarrhea, mesenteric adenitis, terminal ileum inflammation, pseudo appendicitis, sepsis, and other complications. The mechanism of biofilm formation in Y. enterocolitica remains poorly understood, with limited research available on this topic. This study systematically examined the distribution characteristics and biofilm formation ability of Y. enterocolitica isolated from poultry and livestock related samples. Analysis of food samples collected indicated significant presence of Y. enterocolitica (207/670, 30.9 %), particularly in frozen duck meat (7/11, 63.6 %). Majority of the isolated strains did not demonstrate biofilm-forming ability (52.7 %), while a notable percentage exhibited moderate (6.8 %) to strong (11.6 %) biofilm-forming ability. Additionally, a significant percentage of strains (16/207, 7.7 %) displayed extremely high optical density/cut-off OD (OD/ODC) ratios (the average OD value of each sample divided by the average OD value of the negative controls of each 96-well plate plus 3 standard deviations) (exceeding 10). Time-course analysis of biofilm formation in 10 isolates revealed three distinct patterns: (i) rapid increase from 6 h to 12 h, with gradual peak between 48 and 72 h followed by a slight decline and stabilization; (ii) little biofilm formation at 24 h with a gradual increase up to 96 h, maintaining this level until 120 h; and (iii) complete absence of biofilm formation throughout the experiment. Subsequent examination of differentially expressed genes (DEGs) in planktonic cells and biofilms of two strains with distinct biofilm formation capabilities identified seven metabolic pathways, including ribosome, photosynthesis, fatty acid degradation, valine, leucine, and isoleucine degradation, as well as pinene, camphor, and geraniol degradation. Significantly elevated expression levels of genes associated with flagellar assembly, bacterial chemotaxis, and quorum sensing (partially) were observed exclusively in planktonic cells of the selected strain with stronger biofilm-forming ability, implying that the heightened expression of flagellar assembly and bacterial chemotaxis-related genes is an important but not sole determinant of biofilm formation. The study contributes to the elucidation of the underlying mechanisms governing biofilm formation in Y. enterocolitica and may offer valuable insights for the advancement of novel food safety strategies.

News (Medical) associated with Ileitis

10 Sep 2024

·www.businesswire.com

MRM Health Appoints Grégoire Franoux as Chief Business Officer and Adds Ron Robison to its Board of Directors

GHENT, Belgium--( BUSINESS WIRE )-- MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced the appointment of Grégoire Franoux, M.B.A., to the newly created role of Chief Business Officer. Concurrently, the company has strengthened its Board of Directors with the appointment of industry veteran Ron Robison, M.D. “ We are excited to have Grégoire join our executive team at this pivotal moment for MRM Health, on the cusp of late-stage clinical development for our lead candidate MH002 in ulcerative colitis and pouchitis, from our proprietary CORAL platform designed to harness the full power of the gut microbiome to develop effective and safe therapeutics,” said Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health. “Grégoire’s extensive expertise in corporate development, combined with his strategic acumen, will be crucial as we continue to advance our pipeline and expand our reach. ” Mr. Franoux will lead the company’s business development and corporate strategy, focusing on forging strategic partnerships and driving growth. He brings 20 years of experience in strategic planning, licensing, business development and corporate finance within the biotechnology sector. He joins MRM Health from Belfius Bank, where he was spearheading Corporate Finance and Capital Markets activities in the Life Sciences sector. Prior to joining Belfius, Gregoire held senior business development positions at Oxurion, Gruenenthal GmbH and Flamel Technologies. He holds an M.S. in Biotechnology from ESIEE Paris, an M.S. in International Finance from IAE Aix-Marseille, and an Executive M.B.A. from INSEAD. “ It is an exciting time to join the MRM Health team as the company makes important progress advancing next-generation LBPs for inflammatory, CNS and metabolic diseases. I look forward to optimizing the value of MRM’s potentially life-altering therapies and delivering them to patients in need ,” commented Grégoire Franoux. In addition, MRM Health welcomes Ron Robison, M.D., to its Board of Directors. Ron, who previously served as Vice President at AbbVie, brings over three decades of experience in drug development and commercialization. Ron also served in global senior pharmaceutical R&D leadership roles at several organizations, including Mallinckrodt Medical, Sanofi/Sterling Winthrop, Nycomed, Amersham Health, Abbott and Head of R&D and Chief Medical Officer at Solvay Pharmaceuticals. Ron has overseen the approval of more than 20 new molecular entities worldwide with over ten innovative clinical indications obtained under FDA breakthrough therapy designation. Dr. Robison holds an M.D. from the Oregon Health Sciences University, an M.S. in Medical Informatics/Biomedical Engineering from the University of Utah, and a B.S. from Oregon State University. MRM Health Chairman Werner Cautreels added, “ We are thrilled to have Ron join our Board. His deep industry knowledge and experience progressing assets through clinical and global regulatory development will be invaluable as we continue to grow and develop potentially transformative therapies. ” -Ends- About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL ® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at www.mrmhealth.com .

Executive ChangeBreakthrough Therapy

25 Jul 2024

·www.pharmaceutical-technology.com

Sandoz launches ustekinumab biosimilar in Europe

An image of a patient with psoriasis. Sandoz’s ustekinumab biosimilar is indication for several autoimmune conditions including psoriasis. Image credit: Shutterstock/Fuss Sergey Sandoz has announced the European launch of Pyzchiva, a ustekinumab biosimilar approved for the treatment of several autoimmune conditions including psoriasis and Crohn’s disease. Free Buyers Guide Leading Guide to Injectables (Commercial Dose) Companies in Contract Manufacturing for the Pharmaceutical Industry The document includes detailed information on the manufacturers and suppliers and their products, along with contact details, to inform your purchasing decision. Thank you. Go deeper with GlobalData Reports LOA and PTSR Model - Ustekinumab Biosimilar in Ulcerative Colitis Reports LOA and PTSR Model - Ustekinumab in Pouchitis Data Insights The gold standard of business intelligence. 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Pyzchiva is a biosimilar of Johnson and Johnson Innovation Medicine’s (J&J) Stelara , which is approved for treating plaque psoriasis, psoriasis arthritis, and paediatric plaque psoriasis for patients six years and older and weighing over 60kg, as well as Crohn’s disease. In 2021, a Phase III trial (2020-006115-19) demonstrated equivalent efficacy and comparable safety between the biosimilar and reference treatments. The launch comes after the European Medicines Agency (EMA) approved the therapy in April. Following a US Food and Drug Administration (FDA) approval in June, Sandoz has stated that it intends to launch the biosimilar for the US market in February 2025. The launch came in the wake of an agreement between the Swiss company and Samsung Bioepis, finalised in September 2023. Sandoz holds the commercial rights to Pyzchiva in the US, the EU, the UK, Switzerland, and Canada. Meanwhile Samsung Bioepis retains intellectual property rights and remains responsible for development and supply of the drug. The biosimilar joins the Sandoz’s portfolio of five other biosimilars for autoimmune disorders on the market. Launching Pyzchiva in Europe holds particular significance. The continent has the highest prevalence of psoriasis worldwide, estimated to affect 6.4 million people, with over 85% of cases presenting as plaque psoriasis. Along with North America, Western Europe is also home to the world’s highest prevalence of Crohn’s disease, creating ample demand for cheaper, more abundantly available therapeutic options. See Also: MHRA approves Pfizer-BioNTech’s Comirnaty JN.1 vaccine Pipeline power: Sionna’s AbbVie deal could redefine CF therapeutics According to GlobalData, the market surrounding psoriasis treatments is estimated to have doubled since 2014, potentially reaching $13.1bn globally and $4.13bn in the EU in 2024. While Stelara earned $10.8bn in 2023, the drug sales are estimated to drop to $2.9bn in 2028, as per GlobalData. Pyzchiva is set to benefit from this growing market, with its global sales projected to rise to $120m in 2025 and then further to $339m by 2028. GlobalData is the parent company of Pharmaceutical Technology . While not the sole ustekinumab biosimilar approved in Europe, Pyzchiva is the first that is available in 90mg or 45mg concentrations for injection and as a 130mg concentration for infusion—the same dose strengths shown to be effective for the reference medicine. Ustekinumab targets IL-12 and IL-23, both interleukins, which are key to the pathogenesis of several inflammatory diseases. This inhibits signalling and further cytokine production, reducing inflammation and modulating the body’s immune response. Free Buyers Guide Leading Guide to Injectables (Commercial Dose) Companies in Contract Manufacturing for the Pharmaceutical Industry The document includes detailed information on the manufacturers and suppliers and their products, along with contact details, to inform your purchasing decision. Thank you. 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Drug ApprovalPhase 3VaccineClinical Result

11 Jul 2024

·www.pharmaceutical-technology.com

PharmassêtX gains FDA orphan drug status for IBD drug

The safety and effectiveness of EGCG for IBD were supported by peer-reviewed studies. Credit: MMD Creative/Shutterstock. PharmassêtX has received US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for epigallocatechin gallate (EGCG), to treat pouchitis, a rare form of inflammatory bowel disease (IBD). PharmassêtX’s EGCG, a component of green tea, is being developed as a high-purity, high-potency drug for IBD treatment. The safety and effectiveness of EGCG for IBD were supported by peer-reviewed studies, including a clinical trial. A double-blinded, randomised, placebo-controlled, investigator-initiated clinical study of an EGCG-enriched green tea extract demonstrated clinical and endoscopic improvement in patients with mild to moderate ulcerative colitis, without serious adverse events. Further evidence from a retrospective study showed that most refractory pouchitis patients achieved complete symptom relief with EGCG with no serious adverse events reported. See Also: Explainer: Labour has been elected in the UK – now what? EGCG’s mechanism of action includes targeting NF-κB, a regulator of mucosal immunity. PharmassêtX is working to bring its ultra-pure EGCG drug, PSX-514, into clinical trials. The company has partnered with Canada-based global contract research organisation Alimentiv to expedite the development of PSX-514 and bring it to clinic in 2025. PharmassêtX co-founder and CEO Terry Minton stated: “We are grateful to be positioned to provide a much-needed innovative drug, for which there is already substantial evidence of safety and effectiveness, to the underserved community of pouchitis patients. “Our mission as an organisation is to improve outcomes and enhance quality of life for IBD patients. The granting of this ODD is an important milestone along the critical path to accomplishing that mission.

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