Clinical Research Directory

Study of DISC-0974-201 in Participants With IBD and Anemia

This is a Phase 2, multicenter, randomized, double-blind placebo-controlled study of DISC-0974 to evaluate safety, tolerability, and efficacy in participants with IBD and anemia of inflammation.

Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy

People with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease affecting the colon, have a higher risk of developing colon cancer over time. To catch early signs of cancer, regular colonoscopies are recommended. In this study, the investigators are comparing two advanced methods of examining the colon during these surveillance colonoscopies. One method uses a special dye sprayed inside the colon to highlight abnormal areas (called dye-based chromoendoscopy). The other method uses new technology built into the camera to enhance the view without needing any dye (called virtual chromoendoscopy). Both methods use modern, high-definition equipment. The purpose of this study is to find out if the newer, dye-free method is as good as the traditional dye method at detecting pre-cancerous changes (called dysplasia) in people with IBD. Adults with IBD who are due for a routine surveillance colonoscopy may be invited to take part. Participants will be randomly assigned to one of the two methods. No additional procedures are involved, and only the way the colon is viewed differs. The investigators will also look at how long the procedures take, how many biopsies are needed, any complications, and how patients experience the exam. Participants will be followed over time using national health records to check for long-term outcomes. This research will help doctors better understand which method is most effective and comfortable for patients, and may guide future recommendations for cancer screening in people with IBD.

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.

Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation

Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid (UDCA) treatment in PSC patients.

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.

A Phase 1 Study of PVT401 in Healthy Subjects

The goal of this clinical trial is to learn what happens to PVT401 when it enters the human body and how it affects the immune system. It will also provide information about the safety of PVT401 after a single dose and after multiple doses. The main questions it aims to answer are: Will participants experience any side effects when taking PVT401? How long does it take PVT401 to leave the body after it is administered? Healthy volunteers will participate in either the single ascending dose (SAD) or multiple ascending dose (MAD) phase. In the SAD phase, participants will: stay in the clinic for two nights, get one dose of PVT401 or a placebo intravenously (through a vein) on Day 1, have blood drawn periodically throughout their stay and be monitored for side effects, and return to the clinic for 3 follow up visits over the four weeks after dosing. In the MAD phase, participants will: stay in the clinic for one night prior to each dose of PVT401 or placebo, and get dosed twice a week for 5 weeks. They will have blood drawn periodically throughout the treatment period and be monitored for side effects, and return to the clinic for 4 follow up visits over the six months after dosing.

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.

Elemental 028 Extra Case Studies

Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to support patients with severe impairment of the gastrointestinal tract who may require an elemental diet. An upgraded formulation of Elemental 028 Extra with an increased energy, protein content micronutrient profile has been developed to better meet the nutritional requirements of patients. This series of case-studies aims to evaluate the acceptability, compliance, and gastrointestinal tolerance of the upgraded formulation of Elemental 028 Extra, in 30 adult and paediatric patients (15 powder and 15 liquid), with conditions where there is a severe impairment of the gastrointestinal tract, such as inflammatory bowel disease, short bowel syndrome, intractable malabsorption, allergic disease, and neurodegenerative diseases, and an elemental feed is required. The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies.

A Pilot Study on the Efficacy and Safety of a Novel Synbiotic Formula (SGR11) in Patients With Inflammatory Bowel Disease (IBD)

The goal of this clinical trial is to find out whether a synbiotic formula (SGR11) can improve symptoms and health measures in people with inflammatory bowel disease (IBD). The main questions it aims to answer are: * Does SGR11 lead to overall improvement in a participant's condition after 8 weeks, as measured by the Clinical Global Impression-Improvement Scale (CGI I)? * Is SGR11 safe and well tolerated in people with IBD? Participants will: * Take the study synbiotic formula (SGR11) daily for 8 weeks * Complete symptom and quality of life questionnaires * Provide stool samples and, if applicable, blood samples to measure inflammation and gut microbiome changes * Report any side effects that occur during the study

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.

Diagnosis of Inflammatory Bowel Disease

* To quantify the expression of Nuclear enriched abundant transcript 1 (NEAT1) and Anti-sense Non RNA in the INLK4 locus (ANRIL) to determine their potential role as non invasive diagnostic biomarkers in inflammatory bowel disease. * To evaluate the correlation between the studied biomarkers and both the clinical presentation of the patients and the inflammatory mediators like Nuclear factor κB (NF-KB) signaling pathway.

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of dexamethasone before intravenous infusion of infliximab yields greater benefits than routine prophylactic medication in patients with moderate-to-severe inflammatory bowel disease (IBD). This study is designed to optimize the prophylactic strategy prior to Infliximab treatment and advocate for risk stratification-based individualized prophylaxis regimens to avoid hormonal abuse. Additionally, it will construct a risk score using biomarkers to accurately identify high-risk populations in need of prophylaxis and establish a corresponding predictive model. The study is also intended to reduce the use of unnecessary medications, shorten infusion duration and alleviate the medical burden. It is expected to provide targeted clinical support during the early stage of the disease or the course of treatment, improve the efficacy and precision of individualized treatment for patients, and reduce the physical, psychological and economic burdens caused by ineffective treatment.

Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease

The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.

Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research

The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.

Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD

The primary objective of this research is to gain novel insights into the potential of physical activity in reducing fatigue, improving QoL and GI manifestations in children with IBD. The study design will be composed of two parallel groups to investigate the role of physical activity: on the one hand patients with higher exercise habits, on the other hand children with lower exercise habits. To this end, the two groups of pediatric IBD patients will undergo a 24 weeks exercise programme, adjunctive to their current treatment, quantified by a Health Smartwatch (Garmin Inc.). The primary outcomes will then be characterized by the PedsQoL-MFS, IMPACT-III, PCDAI and PUCAI questionnaires, as well as VO2-max quantification. The proposed research will confirm or refute current hypotheses about physical training suggesting an improvement in quality of life (QoL), fatigue and bowel symptoms in children with IBD. Furthermore, investigating the effectiveness on secondary outcomes including muscle strength and aerobic capacity will be a new contribution to current knowledge.

Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway

Colorectal Cancer (CRC), or bowel cancer, is a serious disease that affects many people globally. The earlier CRC is diagnosed, the better the patient outcomes. The problem with the current diagnostic methods is that they lead to many unnecessary endoscopies (colonoscopies). In Denmark alone, over 30,000 patients every year undergo a colonoscopy without having a serious disease. This puts a major strain on both patients and the healthcare system. This research project aims to solve that problem. COCO-S is investigating oncofoetal chondroitin sulphate-modified proteoglycans (ofCS) to see if ofCS can be used as a novel, unique cancer marker found in the blood. ofCS are special molecules that reappear in most tumour tissues. A method has been developed to detect ofCSs in a simple blood sample. Initial findings from an ongoing study are highly promising. A test using five different ofCS markers has shown very high accuracy in detecting CRC: it correctly identifies 86% of cancer cases (sensitivity) and correctly gives a "negative" result in 97% of cases without cancer (specificity). The results also suggest that high ofCS levels might help clinicians detect adenomas (polyps), which are early precursors to cancer. Combining the analysis of ofCS in the blood with the existing stool test (FIT) and other promising blood markers can significantly improve patient selection for a colonoscopy. This project will collect blood samples from patients scheduled for a colonoscopy. The blood will be analysed for ofCS and other substances to determine the combined predictive value for patients who truly require the procedure. The findings from this project could revolutionize CRC diagnosis. By more accurately identifying patients who need a colonoscopy, the number of unnecessary, invasive procedures can be reduced while maintaining patient safety and ensuring cancer is found in time.

Impact of Obesity on Response to Therapy and Clinical Outcom in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), is a group of chronic relapsing inflammatory disorders of the gastrointestinal tract. Its pathogenesis is multifactorial, involving genetic predisposition, environmental triggers, immune dysregulation, and microbial imbalance. IBD has significant morbidity and a major impact on quality of life, with varied clinical presentations and disease behavior (1,2). Obesity, defined as excessive body fat accumulation, is increasingly prevalent worldwide. It is now recognized as a state of chronic low-grade systemic inflammation due to adipose tissue secreting pro-inflammatory cytokines such as TNF-α and IL-6 (3,4). These cytokines may interact with pathways relevant to IBD, particularly in altering the immune response and intestinal inflammation (5). recent studies suggest that obese IBD patients may experience a different disease phenotype, increased complications, and lower response rates to certain biologics, especially anti-TNF agents (6,7). In addition, obesity can alter drug pharmacokinetics, leading to reduced drug efficacy (8,9). Despite increasing evidence of this association, there is limited local data evaluating the prevalence of obesity in IBD and its impact on treatment response and disease outcome (10,11). Understanding this link could help improve personalized treatment approaches and predict treatment outcomes in IBD patients (12,13). Obesity has emerged as a modifiable factor that may influence the clinical response to therapy in patients with inflammatory bowel disease (IBD). Recent studies have shown that higher body mass index (BMI) is associated with reduced steroid-free clinical remission rates in patients treated with advanced biologic and small molecule therapies. The inflammatory nature of adipose tissue, altered pharmacokinetics, and increased drug clearance in obese individuals might explain the suboptimal therapeutic outcomes observed in this population

A Clinical Study on The Use of DL-endopeptidase-producing Probiotics as an Adjunctive Therapy for Inflammatory Bowel Disease.

Through a series of studies,the investigators has discovered for the first time that gut microbiota-derived DL-endopeptidase is a core regulator of the NOD2 pathway. This research also reveals a novel etiological mechanism in which deficiency of gut bacterial DL-endopeptidase leads to dysfunctional NOD2 signaling, thereby promoting the pathogenesis of inflammatory bowel disease (IBD).( The findings have been published in Cell Host \& Microbe and Nature Communications.) Based on this, the investigators has successfully screened a high DL-endopeptidase-producing active strain, Lactobacillus rhamnosus CALM 607 (abbreviated as LR607), from the traditional probiotic Lactobacillus rhamnosus.(Its unique advantages include: 1) Independent intellectual property rights (patent applied for);2) DL-endopeptidase production and NOD2 regulatory ability 2.7 times higher than that of the conventional strain LGG;3) Preclinical experiments have demonstrated its potential to alleviate intestinal inflammation.) The investigators' Phase I clinical trial (data pending publication) has confirmed that LR607 has good safety and tolerability in healthy volunteers, providing a safety foundation for subsequent clinical studies. Therefore, the investigators aim to investigate the DL-endopeptidase-producing probiotic LR607 through randomized controlled clinical intervention studies, to evaluate its adverse effects in adjunctive therapy and comprehensively assess its impact on the gut microbiome-NOD2 pathway, intestinal inflammation, and the progression of IBD.

Efficacy of Individualized Aerobic Exercise Training in Patients With Inflammatory Bowel Disease

The goal of this clinical trial is to learn if a 12-week individualized aerobic training program helps manage inactive or mildly active inflammatory bowel disease (IBD) including Crohn's disease (CD) and ulcerative colitis (UC) in adult patients aged 18-65 years. It will also assess participant compliance and the safety of the training program. The main questions it aims to answer are: 1. Does this aerobic training program improve the cardiopulmonary function of participants? 2. Does this aerobic training program help control disease activity? 3. Does this aerobic training program improve participants' quality of life? Researchers will divide participants into two groups. One group will participate in the training program directly. The other group will first undergo a 12-week control intervention (i.e., standard treatment) before proceeding to the training program. Participants will: 1. Take part in the individualized aerobic training program according to their baseline physical activity level for 12 weeks. 2. Visit the clinic once every 4 weeks for check-ups and tests. 3. Keep a diary of symptoms.

Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease

This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.

Automated Clinical Pathway for Inflammatory Bowel Disease Care

Pragmatic randomized controlled trial to evaluate the effect of an electronic medical record-based tool on improving on-time follow up and its effects on inflammatory bowel disease outcomes

A Trial of Academic Detailing to Promote Prescribing of Biosimilars

The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are: 1. Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab? 2. Do in-person or virtual visits work better? Researchers will compare clinicians offered the educational outreach visit to those who are not offered the visit to see if there is a difference in prescribing of biosimilar versions of adalimumab instead of the original brand-name version. Participants will be offered the chance to meet with a trained clinician who will provide educational information tailored to their knowledge and attitudes on the topic. They will also be provided an educational brochure and patient educational materials.

Evaluation of the SMART IBD App in Pediatric IBD

The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.

Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD

This study explores whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) eat fewer ultra-processed foods (UPFs). UPFs include packaged snacks, sugary drinks, and fast food-items that are high in added sugars, fats, and artificial ingredients. Participants will complete online food recalls to measure what they eat and will then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Researchers will compare changes in UPF intake between the two groups after several weeks and ask families how useful and acceptable they found the materials. The goal is to identify an effective, practical way to support healthier eating habits and long-term gut health in pediatric IBD.