Ulcerative Colitis (UC)

The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.

Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online pain educations programs among adult patients with inflammatory bowel disease (IBD) who experience chronic pain. Each online program can be accessed on the patient's personal device, and will take about 2 hours to complete. Clinical outcomes (pain intensity, pain interference, quality of life) will be assessed via online surveys at baseline and then weekly for 8-weeks post-treatment.

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.

In this study our Research Hospital San Donato Policlinic ask your partipation with the aim to evaluate the risk of cardiovascular complication (i.e. stroke, myocardial infarction) in patients with inflammatory bowel disease. Multiple parameters (therapy, disease activity, life style) and investigations (DNA, stool, lab tests) will be evaluate with the support of artificial intelligence methodologies to better define the cardiovascular risk.

Evaluate the effects of PEA supplementation on disease activity, health-related quality of life (HRQoL) and inflammatory biomarkers in patients with active mild-to-moderate UC.

This observational study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy. Participants who have not previously received anti-TNF treatment and are about to start advanced therapy will provide a blood sample to test for the genetic markers. Participants will also undergo regular assessments of current treatment, disease activity, and inflammatory markers during follow-up.

The purpose of this phase III, multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Hemay005 compared to placebo as induction and maintenance therapy in Chinese participants with moderately to severely active ulcerative colitis.

Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that requires regular monitoring of disease activity. Currently, assessment depends on invasive colonoscopy or clinical scores that may not accurately reflect intestinal inflammation. This study aims to evaluate whether urinary Prostaglandin E-Major Metabolite (PGE-MUM) can serve as a non-invasive biomarker to discriminate disease activity in patients with ulcerative colitis. This cross-sectional study will be conducted at Al-Rajhi University Hospital, Assiut University, Egypt.This study plans to enroll 114 adult patients (≥18 years) with confirmed UC diagnosis, divided into two equal groups: active disease and remission (57 patients each). Disease activity will be assessed using the Mayo Endoscopic Score (MES) and Clinical Activity Index (CAI). Urine samples will be collected from all participants to measure PGE-MUM levels. Blood samples will be tested for CRP, CBC, albumin, and creatinine. Colonoscopy with biopsy will be performed for endoscopic scoring and histopathological assessment using Geboes score. The primary outcome is to establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with UC. Secondary outcomes include comparing PGE-MUM with CRP, determining the optimal cut-off value, and correlating PGE-MUM levels with MES and Geboes score. If successful, urinary PGE-MUM could provide a simple, non-invasive, and cost-effective method for monitoring UC activity in the Egyptian healthcare setting, reducing the need for frequent colonoscopies and overcoming cultural barriers associated with stool collection.

The goal of this clinical trial is to learn how oral vancomycin therapy may contribute in treating paediatric inflammatory bowel disease, particularly atypical ulcerative colitis and PSC-associated colitis. It will also give more information on how this treatment affects gut microbiota and metabolism. The main questions it aims to answer are: 1. Does oral vancomycin improve disease activity and lead to remission (based on symptoms, biomarkers, and endoscopy findings)? 2. How does oral vancomycin change gut metabolism? 3. Does different types of colitis respond differently to oral vancomycin? Researchers will compare children receiving oral vancomycin plus standard therapy to those receiving standard therapy alone. The gut metabolisim before and after oral vancmycin will also be compared, as well as to healthy controls and children with typical ulcerative colitis. Participants will: 1. Take oral vancomycin (if assigned) together with conventional treatment for at least 3 months and up to 12 months depending on response 2. Visit the clinic approximately every 3 months for checkups, tests, and monitoring 3. Provide blood, stool, and saliva samples to study disease activity and microbiota activity 4. Undergo clinical assessments such as symptom scoring, imaging, and possibly endoscopy 5. Complete questionnaires about quality of life 6. Be monitored for side effects and treatment response throughout the study period

This study aims to test whether a short liquid-based diet, followed by a low-sulfur eating plan, is safe, manageable, and helpful for people with mild to moderate ulcerative colitis. Investigators want to see if this approach can improve gut health, lower inflammation, and reduce symptoms. Investigators will also test breath samples as an easy, non-invasive way to track gut bacteria activity and disease changes. Investigators believe this diet plan can reduce harmful gut bacteria that produce irritating sulfur compounds, leading to better gut health and measurable improvements that can be detected through breath testing.

This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with mild-to-moderate, objectively active ulcerative colitis. The supplement is food-grade and is intended for use either alongside stable standard ulcerative colitis therapy (5-aminosalicylic acid/mesalamine) or in participants not currently on any inflammatory bowel disease therapy. Approximately 162 participants will be enrolled at university hospital centers in Turkey and randomized in a 1:1 ratio to receive either the food supplement or matching placebo for 24 weeks, in addition to their existing background therapy as defined by eligibility. The primary objective is to determine whether the supplement increases the proportion of participants achieving composite clinical-plus-biochemical remission at Week 24. This composite endpoint requires absence of rectal bleeding, improvement in stool frequency, fecal calprotectin ≤250 micrograms/g, and no rescue therapy, prohibited treatment escalation, ulcerative colitis-related hospitalization, colectomy, or discontinuation for lack of efficacy before Week 24. Key secondary endpoints include endoscopic improvement, deep biochemical remission, change in fecal calprotectin, change in partial Mayo score, corticosteroid-free composite remission, change in quality of life, change in C-reactive protein, time to treatment failure, and safety. Exploratory analyses will assess stool microbiome composition, eukaryotic carriage including Blastocystis, and associations between baseline microbiome features and treatment response.

A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.

Prospectively study the correlation between Leucine-rich α2-glycoprotein (LRG) and clinical/endoscopic/histological disease activity in patients with inflammatory bowel disease (IBD) in Europe.

The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.

Micronutrient deficiencies are common in ulcerative colitis (UC). Selenium deficiency is associated with worse disease outcomes including disease flares and need for surgery. Previous in vitro and in vivo studies demonstrated that selenium regulates colonic inflammation, and that selenium supplementation protects against DSS-induced colitis. In this proof-of-concept clinical trial, we aim to test the hypothesis that selenium supplementation in moderate to severely active UC patients will improve responsiveness to advanced therapy such as biologics and small molecules.

The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan

A study to assess the safety and effectiveness of Velsipity Tablets 2 mg during long-term treatment (up to a maximum of 52 weeks) in patients with ulcerative colitis under actual medical practice.

Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a AI-enhanced Virtual Reality (VR) Cognitive Behavioral therapy (CBT) program versus distraction VR among patients with inflammatory bowel disease (IBD) and anxiety. It is hypothesized that using VR/AI CBT may reduce anxiety and IBD symptoms, leading to improved overall physical, psychological, and social functioning when compared to distraction VR.

Ulcerative colitis (UC) is a chronic bowel disease. It causes inflammation of the rectum and sometimes the colon. This disease can also affect other parts of the body. It can be very difficult to live with on a daily basis. People with UC may experience frequent diarrhea, rectal bleeding, urgency to defecate, and even incontinence. All of this can significantly reduce their quality of life. The goal of treatment is twofold: * To eliminate or reduce symptoms (this is clinical remission), * To allow the bowel to heal. When these two goals are achieved, the risk of relapse, hospitalization, surgery, or colorectal cancer decreases. To monitor the progression of the disease, gastroenterologists use a test called fecal calprotectin: this is a protein measured in stool that helps detect intestinal inflammation. When conventional treatments like corticosteroids or immunosuppressants are ineffective or poorly tolerated, the investigators use more targeted therapies. For a long time, doctors have used drugs called anti-TNFs. They block a protein responsible for inflammation (TNF-alpha). These treatments are often injected under the skin, which is generally well-tolerated by patients. A drug called infliximab, now available as a subcutaneous injection, could be used as a first-line treatment for ulcerative colitis because it appears to be more effective than other injectable anti-TNFs. Another drug, vedolizumab, works differently from anti-TNFs and can also be used as a first-line treatment. More recently, new classes of drugs have shown promise: * JAK inhibitors (such as filgotinib), * interleukin-12 and interleukin-23 inhibitors (such as ustekinumab). These new treatments have advantages, such as the oral administration method for filgotinib and the fact that they can be used alone, without any other associated medication, which could simplify patients' lives and improve their quality of life. Today, there are increasingly more different treatments for ulcerative colitis, and the investigators still don't know clearly what the best strategy is: Is it better to start with one type of medication rather than another? Does the order in which the investigators try treatments lead to different results? This is an important question for gastroenterologists, as their goal is to choose the most appropriate treatment for each patient from the outset. The main objective of this research is to compare four strategies, corresponding to four treatment arms, starting with the use of infliximab, filgotinib, vedolizumab, or ustekinumab, to maintain remission in patients with ulcerative colitis. The following four arms are therefore proposed: * Based on efficacy: infliximab - filgotinib - ustekinumab - vedolizumab * Based on safety: ustekinumab - vedolizumab - infliximab - filgotinib * Based on current practice: vedolizumab - infliximab - filgotinib - ustekinumab * Based on convenience and route of administration: filgotinib - ustekinumab - vedolizumab - infliximab This study will also allow for a comparison of the efficacy, safety, participant acceptability, and quality of life of the four treatment regimens. This study is intended for adult patients (aged 18 to 65), male or female, with moderate or severe ulcerative colitis (UC) for at least 3 months. Treatment for these patients must require biologic therapy, as determined by the investigator. Participants must be able to provide informed consent to participate in the research and must be covered by a national health insurance plan. Women of childbearing age must be using active contraception for at least the duration of the study (2 years). Patients will be followed for two years. They will be seen at the initial visit, then every two months during the first year, and then every three months during the second year. At each visit, they will be required to undergo blood and stool tests and complete a questionnaire. Endoscopies will be scheduled for weeks 16, 52, and 104. Patient treatments can be optimized once, and based on the endoscopic score, patients may change treatments according to a predefined sequence.

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic immune-mediated disorder requiring long-term management. Clinically, IBD may involve recurrent intestinal inflammation, ulcer formation, and complications such as strictures and fistulas. The etiology of IBD is associated with immune dysregulation, gut microbiome imbalance, and genetic susceptibility. Its clinical manifestations are heterogeneous; early symptoms such as abdominal pain, diarrhea, weight loss, hematochezia, or anemia often resemble gastroenteritis, irritable bowel syndrome, or infectious enterocolitis, leading to misdiagnosis and delayed diagnosis. According to international studies, the interval between initial symptom onset and confirmed diagnosis can range from several months to years, during which untreated disease progression increases the risks of hospitalization, surgery, bowel strictures, and fistulizing complications, resulting in significant impacts on patient quality of life. This study adopts a retrospective design, analyzing our hospital's electronic medical record data from 2023 to 2025.The objective is to evaluate the performance and feasibility of an artificial intelligence (AI) model-developed and incorporating natural language processing (NLP) and phenotypic recognition algorithms-in supporting early identification and diagnosis of IBD. The model has been validated in multiple European healthcare systems and is capable of recognizing high-risk phenotypic clusters from large-scale structured and unstructured medical data. This study represents the first application of this AI technology in the Taiwanese IBD population. All data processing will occur within a de-identified and secure computing environment to ensure data privacy and information security. The study will compare AI-generated diagnostic suggestions derived from medical records with actual clinical diagnoses to assess consistency and accuracy. The model's performance across different clinical characteristics, disease severity levels, and stages of illness will also be examined. In addition, statistical metrics such as precision and recall will be used to generate PRC curves for determining the optimal diagnostic threshold. The outcomes of this study are expected to validate the potential of AI technology in facilitating early recognition, accelerating diagnosis, and supporting clinical decision-making for IBD. The findings will provide essential data for developing localized AI models for IBD, ultimately enhancing diagnostic efficiency, shortening the diagnostic timeline, and improving long-term patient outcomes and quality of life. Objective 1：To retrospectively analyze the clinical characteristics and diagnostic pathways of patients with IBD (CD/UC). Objective 2：To evaluate the performance of the AI model in identifying and providing diagnostic suggestions for high-risk IBD cases. Objective 3：To compare the accuracy and consistency between AI-generated diagnostic suggestions and actual clinical diagnoses.

Healthcare contributes approximately 4.4% of global GHG emissions, with diagnostic imaging and endoscopic services being substantial contributors. Colonoscopy and cross-sectional imaging modalities, though indispensable, are associated with high carbon emissions due to electricity use, waste, sterilisation, and transportation. IBUS, a non-invasive, real-time diagnostic modality, is increasingly validated for disease activity assessment in both UC and CD.

The aims of the study are 1. to determine the effect on dysbiosis, permeability and inflammatory activity after administration of a Mediterranean like diet (a Nordic equivalent, "Nordiet"), 2. to investigate life style related factors, such as exercise, psychosexual health and quality of life and their relation to the disease activity.

The gut microbiota plays a key role in immunity and metabolism and contributes to diseases such as recurrent C. difficile infection (rCDI), ulcerative colitis (UC), and metabolic syndrome (MetS). Microbiota therapeutics, particularly fecal microbiota transplantation (FMT), show promise-achieving \~90% cure rates in rCDI-but demonstrate variable efficacy in chronic conditions. Microbiome engraftment appears critical for FMT success, yet consistent predictors remain lacking. A meta-analysis of 20 FMT studies by our group and the Segata Lab linked engraftment to clinical response across diseases, with taxon-specific patterns and ML-based predictability. While viral, fungal, host immune, genetic, and metabolic factors may affect engraftment, their roles are not well-defined. Key unresolved questions include the interplay among host factors, microbial strains, and metabolites, their influence on engraftment, and impact on clinical outcomes. This study aims to unravel microbiome engraftment dynamics and link them to therapeutic response.

It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ induction. However, the safety of UPA used in situations such as infection and tumors is inferior to that of VDZ, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy, can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe UC patients with VDZ and UPA.