Clinical Research Directory

Food Limitations In Crohn's Disease and Ulcerative coliTis

The goal of this clinical trial is to increase the knowledge on what type of diet affects inflammation and how to better convay that information in patients with inflammatory bowel disease (IBD) and decrease selective eating in patients with IBD. The main questions it aims to answer are: * will the use of calprotectin as a control for changes in inflammation decrease selective food choices? * will the use of a digital information tool increase quality of life (QoL) och decrease selctive eating patterns? * will a diet based on nordic food choices decrease inflammation and increase QoL? Researchers will compare with IBD-patients in ordinary care. Participants will eat a test diet during six weeks or go through a digital information tool.

Palmitoylethanolamide in Ulcerative Colitis

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.

Eating Disorders in Patients With IBD

Inflammatory bowel diseases (IBD) may influence eating habits and lead some patients to adopt restrictive dietary behaviours to control gastrointestinal symptoms. In some cases, these behaviours may become maladaptive and resemble eating disorders, including avoidant/restrictive food intake disorder (ARFID). This observational cross-sectional study assesses the prevalence of eating disorder risk and ARFID risk among adult patients with IBD. Participants complete validated questionnaires evaluating eating behaviours, nutritional status, and IBD-related disability. Clinical and demographic data are also collected.

Validation of the Reliability and Validity of the New Endoscopic Scoring System for Ulcerative Colitis (CAT-DESIRE Score) and Verification of Its Clinical Practicability

Ulcerative Colitis (UC) is a chronic, non-specific intestinal inflammatory disease of unknown cause, featuring abdominal pain, diarrhea, and bloody stools. Endoscopy shows diffuse, continuous lesions with erosion and shallow ulcers, worst in the rectum and diminishing proximally. Current treatments (aminosalicylates, corticosteroids, immunosuppressants, biologics, small molecule drugs) are not curative. Endoscopic mucosal healing is a key treatment goal, improving steroid-free remission, reducing colectomy rates, recurrence, hospitalization, and colorectal cancer risk. Common endoscopic scoring systems: Baron score (poor consistency), Mayo Endoscopic Score (MES, simple but lacks prognostic info), and Ulcerative Colitis Endoscopic Severity Index (UCEIS, more detailed and consistent but cumbersome). Disease extent is important for severity, as proximal extension increases relapse, treatment escalation, and cancer risk. However, MES and UCEIS assess only the worst segment, underestimating total disease burden. Other scores (UCCIS, MMES, DUBLIN) attempt to incorporate lesion extent but have limitations (small samples, lack of validation, unclear severity cutoffs). Data on short-/medium-term endoscopic changes and long-term outcomes are scarce. We therefore propose a new endoscopic scoring system, the CAT-DESIRE score, aiming to evaluate its reliability, validity, and predictive role in medium-/long-term prognosis and treatment response, providing a simple, accurate tool for assessing disease burden and guiding clinical decisions.

Zymfentra (Infliximab-dyyb) REal World Cohort STudy

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.

Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies

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.

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

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.

An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis

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.

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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

FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled Trial

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.

Prospective Evaluation of the Carbon Footprint and Clinical Utility of IBUS Compared to Colonoscopy and Enterography in UC and CD

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.

NORDTREAT Prospective Study on Inflammatory Bowel Disease

Inflammatory bowel disease (IBD), primarily ulcerative colitis (UC) and Crohn's disease (CD), is a chronic disease entity affecting individuals of all ages, and which may severely impact the lives of the patients and their families as well as society. Individuals with IBD may have to live with relapsing symptoms, such as diarrhea, abdominal pain, and fatigue. Further, a substantial proportion of patients develop serious complications such as bowel obstruction and fistula, and some develop complicating liver disease and eventually colorectal cancer. The consequences are that many patients suffer hospitalizations, recurring sick-leave, life-long medication, and surgical interventions. As IBD has become increasingly common in Western populations there is a clear need to improve the outcome from IBD. IBD is a heterogeneous disease entity with substantial differences between patients and personalized medicine may help provide strategies for better treatment . Currently, one of the main unmet needs is the glaring lack of robust biomarkers for individual disease characterization. This lack leads to delayed diagnosis, worse outcomes, increased mortality and an amplified disease burden. Furthermore, diagnosis of IBD is difficult and early diagnosis is crucial as it helps avoid the development of irreversible organ damage. Therefore, there is an emerging focus on the development of simple, non-invasive, and cheap biomarkers to support clinical decision-making in IBD. This Nordic, prospective, clinical study has the aim of identifying markers that are associated with the diagnosis of IBD and prediction of clinical outcomes with various disease manifestations. Importantly, this study will evaluate the markers in a relevant clinical setting, i.e. among patients referred to the hospital for suspicion on IBD using the ECCO Criteria. Specifically the aims of the study are to: * Improve the accuracy to diagnose IBD * Improve the accuracy to define the prognosis of IBD The study is approved by the local Ethics Committee (S-20200051) and the local Data Agency (20/54594).

Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease

The goal of this retrospective study is to learn about dosing patterns in patients starting subcutaneous vedolizumab administration and patient outcomes after starting subcutaneous administration. Patients with IBD who are starting subcutaneous vedolizumab administration between September 1, 2023, and March 31, 2025, as part of normal patient care, will be retrospectively reviewed and analyzed.

Study of XmAb942 in Healthy Participants and Participants With 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).

Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants

This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of intravenously administrated ALTB-268 in healthy participants.

Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults

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.

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

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.

Multi-omics Dissection of Gut Microbiome Engraftment During FMT

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.

Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis

This study is a randomized controlled clinical trial evaluating whether two therapeutic dietary approaches - a ketogenic diet and a carnivore (lion) diet - can improve quality of life, reduce symptoms, and influence measures of disease activity in adults with inflammatory bowel disease \[ulcerative colitis and Crohn's disease\] (IBD) or rheumatoid arthritis (RA). Participants will be randomized into one of three groups: 1) Ketogenic Diet, 2) Carnivore (Lion) Diet or 3) Wait-List Control. Participants randomized to a dietary group (ketogenic diet or carnivore diet) will be provided guidance on their specific dietary therapy and answer questions about their symptoms and quality of life at different intervals over a 24 week period. Participants will also complete laboratory testing at different intervals to assess for changes in nutritional status, cardiometabolic health and markers of immune activation and inflammation. Participants initially placed on the wait-list group will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group. Participants on the wait list will then be compared to participants following a specific dietary pattern to assess for any differences between the 2 groups. After 12 weeks, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and followed in a similar fashion for an additional 12 week period.

Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission

IDEA is a Phase IV, prospective, randomised, open-label, multicentre clinical trial designed to evaluate the safety and efficacy of withdrawing thiopurines in elderly (≥60 years) patients with ulcerative colitis (UC) who are in sustained clinical and biological remission. The study compares discontinuation of thiopurines versus continuation while maintaining background mesalamine therapy over 24 months of treatment.

A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis

The goal of this clinical trial is to learn if MB-001, an oral biologic, is able to treat patients with ulcerative colitis. Participants will be asked to take MB-001 or a matching placebo once-daily for a period of 12 weeks. Researchers will compare MB-001 to placebo to investigate its effects on clinical symptoms as well as endoscopic and histopathological findings. Patients will be offered open-label extension for another 12 weeks following the double-blind, placebo-controlled part of the study. Participants will keep a daily diary to record their symptoms and will have up to nine clinic visits.

STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission

The goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with UC who de-escalate (decrease or discontinue) medical therapy. Both treatment strategies are considered within regular medical practice. Researchers want to find out whether remission can be maintained after de-escalation of therapy. Participants will be: * either be randomly assigned to continue medical therapy or de-escalate medical therapy -OR- be assigned per the participant's preference * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes

The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC

This study will evaluate the efficacy and safety of 627 in patients with UC.

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.