Clinical Research Directory

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.

Effectiveness and Safety of Mirikizumab in Patients With Moderate-to-severe Ulcerative Colitis: a Real-life Retrospective Multicenter Study

This is a real-life, multicenter, retrospective observational study with the aim to evaluate effectiveness and safety of Mirikizumab in a real life setting from the baseline up to manteinance at 12, 24 and 52 weeks. Patients with UC who have started mirikizumab will be included. Patients \> 18 years, with no distinction based on age, demographic group, special population, or general health status will be included. Eligible patients will be identified at each participating center among those receiving mirikizumab as part of routine clinical practice.The primary objective of this study is to evaluate the effectiveness of treatment in achieving clinical remission at week 12, as well as endoscopic remission at weeks 24 and 52. The secondary objectives are to assess changes over time in clinical, biochemical, and imaging parameters. Specifically, the study will evaluate changes in bowel urgency as measured by the Urgency Numeric Rating Scale (NRS), as well as changes in fecal calprotectin and C-reactive protein (CRP) levels from baseline to weeks 12, 24, and 52.

A Phase Ib/IIa Study of INT-210 Capsules in Participants With Active Ulcerative Colitis

A Multicenter, Randomized, Open-label Clinical Study to Evaluate the Safety and Efficacy of INT-210 Capsules in Participants with Active Ulcerative Colitis. The study aims to evaluate the safety, efficacy, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics of INT-210 in participants with active ulcerative colitis (UC).

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab. Patients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year. Guselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care. Researchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy. The goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.

Narrow Band Imaging Versus Artificial Intelligence for Colonic Surveillance in Inflammatory Bowel Disease

Patients with inflammatory bowel disease (IBD) - ulcerative colitis or Crohn's disease - have a higher risk of developing colorectal cancer than the general population. For this reason, regular colonoscopies are recommended to look for early warning signs, such as abnormal areas of tissue called dysplasia, which can develop into cancer over time. Finding these abnormal areas during colonoscopy can be difficult because IBD causes ongoing inflammation that can make the bowel mucosa look irregular, hiding subtle changes. Doctors currently use a technique called narrow-band imaging (NBI), a special light setting on the colonoscope that enhances the visibility of the bowel, to help spot these areas more easily. A newer tool, artificial intelligence (AI)-assisted detection, has shown promise in helping doctors find more polyps during routine colonoscopies in the general population. However, this AI tool was developed and tested mostly in people without IBD, so it is not yet known whether it works as well in people with IBD, whose bowel can look very different due to chronic inflammation. This study will directly compare the AI tool (CADe; ENDO-AID, Olympus) with narrow-band imaging to see which one is better at finding abnormal areas during colonoscopy in patients with long-standing ulcerative colitis or Crohn's disease who are having their routine cancer surveillance exam. Each participant will have one colonoscopy in which the bowel is examined twice in a row, once with each technique, by two different doctors, in random order. This lets researchers compare both methods directly within the same patient, which is the fairest comparison. The study aims to enroll 60 patients at Vall d'Hebron University Hospital in Barcelona, Spain. Researchers hope the results will help determine whether AI tools - which are widely available and easier to use than NBI - can be a reliable alternative for IBD surveillance, potentially making this important cancer-screening exam more accessible in the future.

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.

Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active ulcerative colitis

Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study

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.

Online Pain Education for Crohn's Disease and Ulcerative Colitis

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.

Ulcerative Colitis Permeability

Study aim: To investigate whether the values of zonulin and lipopolysaccharide-binding protein (LBP) as biomarkers of intestinal permeability are related to the degree of liver steatosis, steatohepatitis and fibrosis in patients with ulcerative colitis (UC) and metabolic-associated steatotic liver disease (MASLD). Subjects and methods: Participants with UC will be included, except for those whose inflammation affects only the rectum. During the clinical and biochemical remission of UC, a physical examination, taking of anamnestic data, blood tests, and abdominal ultrasound with measurement of parameters of liver steatosis, steatohepatitis, and fibrosis (controlled attenuation parameter, FibroScan-AST score, liver stiffness measure) will be performed via transient elastography. Blood samples will be taken to determine zonulin and LBP, and statistical data will be processed. Expected contribution to the field: Indicate the potential of zonulin and LBP as markers for advanced liver fibrosis in patients with MASLD and UC.

Cardiovascular Risk in Patients With IBD

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.

Effect of Isoflavone and Vitamin D Supplementation on Serum Vitamin D Levels, Body Composition, Inflammatory Markers, and Quality of Life in Patients With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic immune-mediated disorder characterized by recurrent intestinal inflammation, impaired nutritional status, and reduced quality of life. Nutritional deficiencies and alterations in body composition are frequently observed in patients with IBD and may contribute to disease burden and long-term complications. Isoflavones derived from fermented soy products, such as tempeh, have demonstrated anti-inflammatory properties in both experimental and clinical studies. Vitamin D is an important immunomodulatory nutrient, and its deficiency is common in patients with IBD. However, evidence regarding the combined effects of isoflavone and vitamin D supplementation on inflammatory markers, nutritional status, and quality of life in patients with IBD remains limited. This study aimed to evaluate the effects of daily tempeh powder supplementation providing approximately 50 mg of isoflavones and 4000 IU of vitamin D3 for 8 weeks in patients with IBD. Outcomes include changes in serum vitamin D concentration, body composition parameters, serum tumor necrosis factor-alpha (TNF-α), interleukin-10 (IL-10), and quality of life assessed using the Inflammatory Bowel Disease Questionnaire-9 (IBDQ-9).

VIBRANT-IBD: Brain Effects of Non-Invasive Vagus Nerve Stimulation in IBD Remission

The VIBRANT-IBD study is a pilot, prospective, single-arm feasibility study investigating the effects of non-invasive vagus nerve stimulation (nVNS) in adults with inflammatory bowel disease (IBD) in clinical remission. Approximately 15 participants with Crohn's disease or ulcerative colitis will use the Nurosym auricular vagus nerve stimulation device daily for 28 days. Participants will undergo two magnetic resonance imaging (MRI) sessions, one before and one after the intervention. The MRI protocol will include structural imaging, diffusion-weighted imaging, MR angiography, and resting-state functional MRI (rs-fMRI) to assess brain structure and functional connectivity. Before and after the intervention, participants will complete standardised psychological and study-specific questionnaires assessing stress, anxiety, depression, fatigue, emotional functioning, body awareness (interoception), quality of life, gastrointestinal symptom-related experiences, and perceived effects of the intervention. Optional qualitative interviews will additionally explore participants' experiences of living with IBD and using vagus nerve stimulation. The study aims to evaluate the feasibility and preliminary neuropsychological and neurofunctional effects of non-invasive vagus nerve stimulation in individuals with IBD.

Hemay005 for the Treatment of Chinese Moderately to Severely Active Ulcerative Colitis

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.

Use of Psychologist-administered Cognitive Behavioral Therapy (CBT) or Self-administered CBT for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)

This is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with IBD can be improved with CBT compared to those treated with SKY.

Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease

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.

Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity

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.

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).

AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis

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 I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult

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.

Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context

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.

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.

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.

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.