Clinical Research Directory

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

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).

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

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 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.

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.

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).

Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe

The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability

Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance

The goal of this research is to learn how a new device called the wireless thermal capsule (WTC) can collect thermal data to help see diseases that happen in the gastrointestinal (GI) tract, such as Crohn's Disease.

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.

A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting

The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical effectiveness (how well it works) in the overall population and in predefined participant subgroups. The study will also assess patient-reported outcomes, including fatigue (low energy), health-related quality of life (HRQoL), and treatment satisfaction. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).

Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease

The purpose of this study is to investigate whether the gut bacteria in IBD patients cause ongoing abdominal pain, even when the disease is calm. Many inflammatory bowel disease (IBD) patients have this pain, regardless of whether their disease is active or not. This might be linked to an imbalance in gut bacteria. Certain IBD patients with persistent abdominal pain experience increased sensitivity in their gut due to bacteria producing LPC and LPA. Our goal is to explore the connection between bacterial LPC/LPA levels and symptoms in IBD patients with long-lasting abdominal pain. Additionally, we aim to pinpoint the specific bacteria responsible for producing LPC/LPA, which in turn causes chronic abdominal pain in these patients.

Regulation of Mucosal Healing in Inflammatory Bowel Disease

The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing.

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.

FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease.

A Multi-Center Randomized Controlled Trial on the Impact of Disease Subtype-Based Active Video Education on Bowel Preparation Quality in Patients With Inflammatory Bowel Disease

This multi-center, prospective, randomized controlled trial evaluates whether disease subtype-based active video education improves bowel preparation quality in patients with inflammatory bowel disease (IBD) undergoing colonoscopy. A total of 600 IBD patients from 13 centers will be randomized 1:1 to standard education plus subtype-specific video education (intervention group) or standard education alone (control group). The primary outcome is the Boston Bowel Preparation Scale (BBPS) score.

Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC)

The primary objective of this trial is to evaluate the clinical efficacy of ATH-063 in participants with biologic/advanced therapy relapsed/refractory moderately to severely active UC.

Dapagliflozin in Patients With Ulcerative Colitis

The inflammatory bowel diseases (IBD) are described as complex, recurrent inflammatory conditions which are manifested as Crohn's disease (CD) and ulcerative colitis (UC). The common symptoms of IBD include debilitating/severe diarrhea, abdominal pain, weight loss, and chronic fatigue; events that may culminate in life-threatening complications. The pathogenesis of IBD has been characterized as complex/multi-factorial that includes disruption of intestinal epithelial barrier with consequent translocation of commensal microbial products as the prime event that instigates severe immune responses and intestinal inflammation.

Development of the SC-IBD Self-Care Measurement Scale

This study aims to develop and validate a disease-specific self-care measurement scale for patients with Inflammatory Bowel Disease (IBD). The research follows a sequential mixed-methods design: a qualitative phase to identify key self-care concepts, followed by a quantitative phase to test the psychometric properties of the newly developed SC-IBD scale in an outpatient population.

Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy 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. Also, it is associated with high risk of colon cancer, so there is a continuous need for introducing new therapies that decrease progression, and hence better outcomes

IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD

People with Inflammatory bowel disease (IBD) can get challenging symptoms. Things like diarrhoea, tummy pain and being tired all the time are common. People often get IBD in their teens or twenties. They often find working, studying and relationships hard. IBD can't be cured, so it lasts for life. When IBD is hard to treat, we use advanced treatments, but these don't always work. When they do work the effect can wear off. This happens in 2 of 5 people within a year in research studies. There are some things that we know make them wear off. There are lots more reasons that we don't understand yet. We think anxiety, depression and stress make these treatments more likely to wear off. Previous research has suggested that people with IBD do worse if they have anxiety, depression or stress. The investigators want people with IBD to complete questionnaires to see if they are affected by anxiety, depression or stress when they are taking advanced therapies. The investigators will follow those people to see if the effect of their treatment wears off. People living with IBD will contribute to the running and fine tuning of this research. Many of those that have engaged with us so far have said that their disease was worse when their mental health was worse. They were generally supportive of this study to see how anxiety, depression and stress effects IBD in people using advanced therapies. The investigators have talked to a national charity about our work. They will help share the findings so that patients, care givers and other stakeholders will be able to read about them. The results will be published so that doctors and researchers can use them.