Clinical Research Directory

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 Term Persistency of Guselkumab in Adult Participants With Inflammatory Bowel Disease

The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

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.

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.

Duloxetine in Inflammatory Bowel Diseases

This open-label, prospective, single-arm pilot study investigates the use of duloxetine, a central neuromodulator, for improving psychological distress and functional impairment in adults with inflammatory bowel disease (IBD). The study focuses on patient-reported outcomes related to anxiety, depression, and IBD-related disability, aiming to assess feasibility, tolerability, and preliminary efficacy in modulating gut-brain axis symptoms and disease-related functional impairments in life

Atorvastatin in Patients With Ulcerative Colitis

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.

Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.

Feasibility Test of Action Planning in Pediatric IBD

The goal of this interventional study is to test the feasibility of a new communication tool, call MyIBD, in youth ages 13 to 19 years with inflammatory bowel disease. The main question\[s\] it aims to answer are: * Is the MyIBD communication tool feasible to use in everyday clinical practice? * Does the MyIBD tool have potential to improve patients' self-management skills and the quality of care they receive? Participants who receive the MyIBD intervention will complete surveys about their care at three times points - at study enrollment, at 6 months, and at 12 months. The surveys will help the research team learn about the feasibility of using MyIBD in practice and about any effects on patients' self-management skills and quality of care. Researchers will compare those receiving a MyIBD document to a randomly selected control group (patients receiving usual care for pediatric inflammatory bowel disease) to see if self-management skills and quality of care differ between the groups.

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study

To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.

Pathogenic Study of Adult Immune Enteropathies

The study focuses the mechanisms underlying the loss of intestinal homeostasis in celiac disease, refractory celiac disease and other immune diseases such as monogenic enteropathy, inflammatory bowel diseases or drug induced intestinal diseases. Mechanisms of transformation of lymphocytes leading to onset of lymphomatous complications of immune enteropathies will be investigated. Mechanisms of loss of hepatic lymphocytic homeostasis will also be assessed in liver associated diseases.

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.

Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy

For patients with colon polyps (clumps of cells in the lining of the colon) treatment often requires removal of the affected portion of the colon. Both conventional laparoscopic and robotically assisted minimally invasive surgery have been shown to have reduced complication rates and shorter hospital stays. This study aims to look at the use of the VI RASD as a robotic surgical device in right or left colectomy procedures to see if the device performs as intended and is safe for use.

Validation and Clinical Impact of GLIM Criteria in Patients With Inflammatory Bowel Disease

Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic inflammatory conditions of the digestive tract that frequently lead to malnutrition. Malnutrition in individuals with IBD is associated with diminished quality of life, impaired treatment response, and higher rates of hospital admission. To standardize nutritional diagnosis, the Global Leadership Initiative on Malnutrition (GLIM) introduced a consensus framework combining phenotypic criteria (weight loss, low body mass index, and reduced muscle mass) and etiologic criteria (reduced food intake/assimilation and disease-related inflammation). The primary objective of this prospective observational study is to validate the diagnostic accuracy and sensitivity of the GLIM criteria in identifying malnutrition among hospitalized and ambulatory adult patients with IBD, using the Subjective Global Assessment (SGA) as the reference standard. Secondary objectives include determining the prevalence and severity of GLIM-defined malnutrition, evaluating its relationship with clinical, functional, and inflammatory parameters, and identifying clinical predictors of malnutrition in this population. Adult participants diagnosed with IBD presenting to the inpatient wards or outpatient clinics of Al-Rajhi Liver Hospital (Assiut University) will be enrolled. Participants will undergo initial nutritional risk screening using the Malnutrition Universal Screening Tool (MUST) for outpatients or the Nutritional Risk Screening 2002 (NRS-2002) for inpatients. Full nutritional assessment will be conducted via GLIM criteria and SGA. Additional evaluations will include anthropometric measurements (mid-arm muscle circumference and calf circumference), muscle strength testing via handgrip dynamometry, dietary intake assessment, routine laboratory panels (complete blood count, inflammatory markers, liver function tests, electrolytes, and fecal calprotectin), and endoscopic disease activity scores (SES-CD or Mayo endoscopic score) when clinically available.

Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for Crohn's Disease or Ulcerative Colitis

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Crohn's Disease or Ulcerative Colitis

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Efficacy of Accelerated Versus Standard Regiment of Hepatitis B Virus Vaccine Among Inflammatory Bowel Disease Patients

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that includes ulcerative colitis (UC) and Crohn's disease (CD) . They mainly affect young populations, altering their quality of life and increasing morbidity, compared to the general population . The etiology and pathogenesis of IBD are still poorly understood. Inflammatory bowel disease (IBD) patients are at an increased risk of contracting and developing complications from hepatitis B virus (HBV) due to their weakened immune systems and frequent use of immunosuppressive medications. The traditional HBV vaccine regimen requires three doses over six months to achieve full immunity, which can be challenging for IBD patients who may have difficulty adhering to the schedule or may not respond well to the vaccine

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.

Repurposing Fenofibrate in Modulating AMPK/NLRP3 Inflammasome in Patients With Ulcerative Colitis

Fibrates, specific pharmacological agonists of PPARα, have been widely used to treat hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent

Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis

Ulcerative colitis (UC) is one of the most common types of chronic and non-specific inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life. Although the precise pathological mechanism of UC remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of UC, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune response are the key events during colitis development

The Canadian Children Inflammatory Bowel Disease Network (CIDsCaNN)

The CIDsCaNN Network is being established with the major goals of identifying why IBD develops so commonly in children and adolescents living in Canada, and of determining the best treatment strategies for different types of IBD. Focusing on a prospective, inception cohort of Canadian children of widely varied racial origins provides a unique opportunity to explore environmental risk factors early in life and close in time to disease onset, their influence on the host microbiome, and in the context of genetic susceptibility. In keeping with current treatment targets, assessed outcomes will include not only symptom resolution and growth, but also intestinal healing. We aim to identify best practice and to institute processes for continual improvement in care nationally.

Genome Analysis Across Populations in Inflammatory Bowel Disease

Objective: To use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD within affected populations.

A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome

Apart from its use to provide insight in IBS disease courses and in clinical research, ESM can provide patients with feedback about individual triggers of their symptoms, and thereby function as part of a personalized therapeutic strategy. This is also true for IBD-IBS. Treatment strategies in IBS and IBD-IBS are largely based on reassurance, identification and elimination of triggering factors, and in more severe cases pharmaco- and psychotherapy. The ESM approach has the potential to increase therapeutic efficacy in IBS and IBD-IBS and will assist patients in disease self-management. The Traqq application can provide more detailed information about the dietary pattern of IBS and IBD-IBS patients. Traqq in combination with ESM will give an overview of abdominal pain and associated symptoms and psychosocial factors are exposed to during the day. The insight provided using ESM and Traqq may improve patient understanding of their personal symptom dynamics and triggers, as well as the physician's insight into the symptom patters of the specific patients, which may aid treatment choice and eventually improve the outcome of any treatment provided in daily clinical care.

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 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.