Clinical Research Directory

A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea

The purpose of this study is: * to find out out the number of children who develop crohn's disease (CD) and ulcerative colitis (UC) each year and are living with the disease and to see how this differs by age groups. * to understand how children of different age groups are treated over time and how their treatment changes as they grow. * to assess how often children use healthcare services and how much this costs for different age groups over several years. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system) and develop ulcers.

CorEvitas Inflammatory Bowel Disease (IBD) Registry

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for IBD in a cohort of patients cared for by gastroenterologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be directed to recording safety outcomes reported in association with infliximab and other prescribed IBD therapies. In addition, information on disease status and quality of life will be collected.

Inflammatory Biomarkers and Disease Activity in Inflammatory Bowel Disease

This study aims to evaluate the diagnostic accuracy and clinical utility of routine blood-derived inflammatory biomarker ratios in assessing disease activity among adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. Endoscopy is the standard method for evaluating mucosal inflammation in IBD, but it is invasive, costly, and inconvenient for frequent disease monitoring. Non-invasive, inexpensive laboratory markers derived from standard routine blood tests, specifically the C-reactive protein-to-albumin ratio (CAR), platelet-to-albumin ratio (PAR), neutrophil-to-lymphocyte ratio (NLR), fibrinogen-to-albumin ratio (FAR), and hemoglobin-to-CRP ratio (Hb/CRP), have shown potential in reflecting systemic and intestinal inflammation. Participants enrolled in this cross-sectional study will undergo routine clinical disease activity evaluations and standard blood tests. For patients undergoing routine colonoscopy, endoscopic disease activity scores will also be recorded. The primary goal is to determine how accurately these blood-based ratios can differentiate active IBD from disease remission, providing a simple, cost-effective tool for regular patient monitoring.

Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.

Incremental Value of Traditional Chinese Medicine Features in Two-Stage Pre-Endoscopic Prediction

This observational study evaluates whether adding Traditional Chinese Medicine (TCM)-related clinical features improves the performance of machine-learning models that estimate disease risk before colonoscopy. We compare two modeling strategies that use the same sequential (two-stage) framework: Western-only models, based on demographic, clinical, and laboratory information commonly used in Western medicine. TCM-integrated models, which use the same types of Western information plus structured TCM features. Stage 1 aims to distinguish people more likely to have functional bowel problems from those more likely to have inflammatory or neoplastic colorectal disease. Stage 2 focuses on people in the higher-risk pathway and aims to distinguish ulcerative colitis from other inflammatory or neoplastic conditions. Models are developed in one dataset and tested in independent external data from other centers. We assess discrimination (including AUC), clinical usefulness with decision-curve analysis, and which TCM features contribute most in the integrated models. This study does not assign treatments. It analyzes existing clinical information to support future pre-endoscopic triage research. Results will not replace colonoscopy or clinician judgment.

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. The investigators will address the following specific aims: 1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care. 2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care.

Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease

The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease. The main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.

Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease

This randomized controlled trial evaluates whether adding point-of-care intestinal ultrasound (IUS) to standard of care changes clinical management in patients with inflammatory bowel disease (IBD). Adult patients with Crohn's disease or ulcerative colitis undergoing colonoscopy for disease assessment are randomized 1:1 to standard of care plus IUS at every visit, or standard of care alone, and followed for 48 weeks. The primary outcome is the proportion of patients with a change in treatment.

Trial of Mirtazapine for Depression in IBD

This study will test whether it is feasible to conduct a clinical trial of mirtazapine (an antidepressant tablet) in patients who have both depression and inflammatory bowel disease (IBD). The study design is a randomised controlled trial (a study in which people are allocated by chance to receive different interventions). The trial will compare mirtazapine against a placebo (dummy) tablet in 76 patients with both depression and IBD. The investigators will recruit outpatients aged 18 or over with a diagnosis of any IBD attending gastroenterology clinics. Either in person or remotely, patients will complete a brief screening questionnaire for depression. Those scoring positive for depression will be invited for a 15-minute interview for clinical depression. Those with clinical depression will be invited to take part. Participants will be randomly allocated by a computer to take either 1) mirtazapine tablet once at night for 12 weeks; or 2) placebo (dummy) tablet once at night for 12 weeks. The study is 'blinded', meaning neither patients nor the study team will know which medication they are taking. Throughout, participants will be able to access other treatments for depression, such as talking therapies. The investigators will measure how many people join the study; how many remain in the trial; how many complete treatment; how many tablets people take; and assess overall acceptability of the trial. Participants will complete brief questionnaires to measure their mental health and IBD symptoms after 4 weeks, 8 weeks, 12 weeks and 16 weeks. Participants will also provide blood samples and faecal samples to measure inflammation. If successful, this trial will support an application for a larger version of the study.

Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy) or HDWLC with targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time, regardless of the extent of disease (random biopsy strategy). Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy. Follow-up via chart review may continue for up to 15 years from enrollment.

PIBD-SETQuality: the Inception Cohort and Safety Registry

The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated faecal microbiota transplantation (FMT) or faecal microbiota filtrate transplantation (FMFT) compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active Ulcerative Colitis.

Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy

Randomized, placebo-controlled dose-ranging study of 2'-FL in IBD, Crohn's Disease (CD) and ulcerative colitis (UC). The overarching hypothesis is that 2'-FL supplementation in IBD will be safe and well tolerated, while increasing fecal Bifidobacterium abundance and butyrate in a dose dependent manner. The investigators will test 1, 5, or 10 gm 2'-FL compared to 2 gm dextrose placebo as a daily dietary supplement in pediatric and young adult IBD participants in stable remission receiving infliximab, adalimumab, or infliximab-dyyb biosimilar anti-TNF therapy.

BOOM-IBD2 Pivotal Clinical Trial

Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.

Flu Vaccine Response in Patients on Biologic Therapies

This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving immunosuppressive therapies. Subjects will be randomized to receive either one or two doses of influenza vaccination in year #1. In year# 2, all participants will be given two doses of influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination. This study will also assess the immunogenicity and safety of a booster vaccine strategy in the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose strategy will improve both clinical and serologic responses in this vulnerable population.

Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease

Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care. Improving IBD disease control is linked to increased health-related quality of life. Even as many effective pharmacotherapies to promote disease control are available, evidence suggests that Hispanic and Non-Hispanic Black IBD patients may not receive full benefit from these therapies compared to their Non-Hispanic White counterparts. Underlying mechanisms that contribute to observed disparities in the use of IBD medical therapies are likely multifactorial. Adequate access to treatment has been implicated. Hispanic and Non-Hispanic Black IBD patients are more likely to be Medicaid-insured, and Medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal IBD control. Medication adherence has also been proposed as a potential mediating factor. IBD therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. While previous studies suggest Black IBD patients have lower medication adherence than Non-Hispanic White patients, it is unclear the extent to which social factors contribute to this observation. The purpose of this study is to evaluate the association between social determinants of health, medication adherence, and HRQoL among Hispanic and Non-Hispanic Black IBD patients. Understanding potentially modifiable psychosocial factors that contribute to medication adherence and HRQoL will provide targets for later intervention towards the goal of health equity.

Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients

The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with inflammatory bowel disease (IBD). This study is being done to learn if VR-directed BGBT is feasible and acceptable for patients with IBD in addressing pain in the hospital setting. The study hypothesizes that: * At least 75% of enrolled participants will complete the VR-directed BGBT inpatient program * Hospitalized patients with IBD will find VR-directed BGBT acceptable as a pain treatment option in the inpatient setting.

Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease

This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease. The study team hypothesizes: * the study will achieve a recruitment rate of 10 participants every 3 months * 70% participant retention at 24 weeks * 70% outcome data collection * 70% intervention completion * high acceptability

Ex Vivo Study of hAMSC Secretome in Inflammatory Bowel Disease: Effects on Inflammation and Fibrosis (TARGET)

Inflammatory Bowel Diseases (IBD), including ulcerative colitis and Crohn's disease, are chronic immune-mediated disorders characterized by relapsing gastrointestinal inflammation driven by genetic, immune, microbial, and environmental factors. Despite advances in biologic therapies and small molecules, a substantial proportion of patients exhibit incomplete response, loss of response over time, or progression toward structural bowel damage, including fibrosis, for which no approved anti-fibrotic therapies are currently available. Current treatments mainly target single inflammatory pathways and are insufficient to restore the complex immune, epithelial, and stromal network dysfunction underlying disease persistence and progression, particularly in refractory disease and fibrostenotic Crohn's disease. This study investigates the ex vivo effects of human amniotic mesenchymal stromal cell (hAMSC)-derived secretome, a cell-free biologic product containing bioactive mediators and extracellular vesicles with immunomodulatory, anti-inflammatory, anti-fibrotic, and pro-regenerative properties. The secretome is hypothesized to modulate immune responses, epithelial barrier integrity, mucosal repair, and fibrotic pathways simultaneously. Preliminary data in peripheral blood mononuclear cells (PBMCs) show reduced T helper 1 (Th1) polarization with decreased interferon gamma (IFN-γ) and tumor necrosis factor alpha (TNF-α), and increased regulatory T cells (FOXP3+). Ex vivo experiments in Crohn's disease biopsies indicate a shift toward a more tolerogenic and reparative cytokine profile. This monocentric translational study includes 40 adult patients (≥18 years) with confirmed IBD, stratified into four clinical subgroups based on disease activity, treatment exposure, and fibrostenotic phenotype. Intestinal biopsies and PBMCs are collected prospectively and analyzed within 7 days of sampling. The primary objective is to evaluate ex vivo modulation of inflammatory, immune, epithelial, and fibrotic pathways after exposure to hAMSC secretome. Secondary objectives include assessment of fibrosis markers (COL1A1, ACTA2), epithelial barrier proteins (claudin-1, claudin-2, MUC2), barrier function (TEER), and molecular pathway changes using patient-derived organoids and co-culture systems under basal and pro-fibrotic conditions. The study duration is 36 months, including sample collection, laboratory experiments, multi-omics analyses, and data integration.

Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions

The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.