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Ulcerative Colitis clinical trials

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NCT ID: NCT06107179 Recruiting - Ulcerative Colitis Clinical Trials

Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Start date: January 24, 2024
Phase:
Study type: Observational

In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity. The goal of this clinical trial is to compare the optoacoustic signal in the intestinal wall of children with inflammatory bowel diseases. The main questions it aims to answer are: - How does the optoacoustic signal in children with inflammatory bowel diseases change over time? - How does the optoacoustic signal in children with inflammatory bowel diseases change when they receive therapy? Participants will be examined with multispectral optoacoustic tomography.

NCT ID: NCT06095128 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

Start date: June 12, 2024
Phase: Phase 4
Study type: Interventional

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.

NCT ID: NCT06094608 Recruiting - Ulcerative Colitis Clinical Trials

IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.

NCT ID: NCT06080048 Recruiting - Ulcerative Colitis Clinical Trials

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis

Start date: October 24, 2023
Phase: Phase 1
Study type: Interventional

SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).

NCT ID: NCT06073873 Recruiting - Ulcerative Colitis Clinical Trials

A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

Start date: May 30, 2024
Phase:
Study type: Observational

The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.

NCT ID: NCT06071312 Recruiting - Ulcerative Colitis Clinical Trials

FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach

Start date: September 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Clostridioides difficile infection (CDI) is the most frequent cause of infectious diarrhea in hospitalized patients and is responsible for 20-30 % of antibiotic-associated diarrhea cases. Inflammatory bowel diseases (IBD) are associated with an higher prevalence, recurrence and severity of CDI. The prevalence of recurrent CDI in patients with IBD is 2.5 to 8 times higher than in the general population, with a cumulative lifetime risk of 10 %. The higher risk to the development of CDI in patient with IBD is directly related to the microbiome alterations that are associated with this chronic disoder. Moreover, the use of antibiotics to cure CDI further worsens the gut microbiota, triggering potentially a self-maintaining cycle and predisposes such patients to a higher risk of recurrence. In these patients, CD superinfection is associated, with an increased rate of hospitalization, length of stay, the need to modify the treatment to the underlying disease, the increase rate of colectomy, there higher mortality rate, with a net increase of health costs. Nowadays, as emerged by several studies FMT has been established as a valid treatment option against recurrent CDI (rCDI), and it is recommended by international guidelines. Unfortunately, most FMT studies for rCDI have excluded patients with IBD. Recent evidence suggests that FMT is effective in patients with ulcerative colitis (UC) and concomitant rCDI, both in the treatment of the infection and in the improve of disease activity. To date, most studies evaluated the efficacy of single infusion of FMT in these patients. Preliminary data from our group suggest that a sequential approach (i.e., repeated fecal infusions) may increase the efficacy of FMT in this population. Indeed, in 18 patients with IBD, single infusion fecal resulted in eradication of rCDI in 60% of cases, whereas this outcome was achieved in 89% of cases using a sequential approach. Similar data have been demonstrated in a retrospective study by Fischer and colleagues. However, more studies are advocated to confirm these results. Therefore, our study aim to compare the efficacy of single FMT vs. sequential in the eradication of rCDI in patients with UC.

NCT ID: NCT06052059 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

NCT ID: NCT06050811 Recruiting - Ulcerative Colitis Clinical Trials

Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC)

PRInCE-UC
Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The community of microbes living in the gut is called the 'gut microbiome'. Changing this could be an exciting new way of treating people living with ulcerative colitis (UC). UC is a type of inflammatory bowel disease. It affects 4 in every 1000 people in the UK. UC causes severe episodes of inflammation leading to bloody diarrhoea. The gut microbes of people living with UC are different to those in healthy people. This may be part of the reason people with UC have a more inflamed gut. Prebiotics are types of fibre in the diet which help feed the positive microbes in the colon. Eating them can change the make-up and activity of the bugs which live in our gut in a good way. The goal of this clinical trial is to test the effect of a type of prebiotic called a human milk oligosaccharide (HMO) on the symptoms of patients with UC. The main questions it aims to answer are: - Can a prebiotic improve symptoms for patients living with UC? - Can a prebiotic improve the gut microbiota of people living with UC, and improve markers of inflammation, metabolism and immune function? Patients will take a sachet containing either the prebiotic or a placebo for four weeks, then swap to the other sachet. The trial will be double-blind and randomised. This 'crossover' design means patients act as their own control, which is important in gut microbiology studies. The prebiotic's effect on patient symptoms, metabolism and immune system will be measured. The investigators plan to recruit 44 participants over 18 months. Their urine, blood and stool will be tested. This project will be the first 'bench to bedside' study into the use of prebiotics in IBD. The treatment in this project is rooted in gut model studies. Different prebiotics were tested in the lab to determine which was the best to use for the trial. This 'lab first' approach is a first of its kind.

NCT ID: NCT06042387 Recruiting - Healthy Clinical Trials

Diverse Ancestry Study in IBD

Start date: May 1, 2022
Phase:
Study type: Observational

Objective: To use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD in diverse ancestries: African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous ancestry.

NCT ID: NCT06030882 Recruiting - Ulcerative Colitis Clinical Trials

Improving Patient Outcomes Through the Implementation of an IBD Biologic Care Pathway

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

Inflammatory Bowel Disease (IBD) includes a group of chronic inflammatory conditions of the gastrointestinal system and is composed of Crohn's disease and ulcerative colitis. As an immune-mediated disease, IBD treatment options include the use of biologic medicines including anti-tumor necrosis alpha factor (also called anti-TNFs) medication. Despite biologic medicines being an important part of IBD management, there is inconsistency in the way these medications are used. Implementation of evidence-based, standardized biologic care pathways (BCP) can improve treatment related outcomes. Previous research has shown that using a clinical care pathway, such as a BCP, is a feasible method to support clinical decision making and may improve disease-related outcomes for patients. The researchers propose a prospective study to determine how well a BCP can be incorporated into clinical practice, improve patient health outcomes, and reduce healthcare system redundancies. Also, the impact of a BCP on outcomes for patients treated with the help of a standardized BCP compared to those in patients treated without the use of a BCP will be studied. The results of this study will inform how best to incorporate evidence-based BCPs into real-world practice and support the wide-spread adoption of BCPs in clinical practice.