Ulcerative colitis clinical trials — recruiting now

This is a small pilot study of the fermented soybean extract MicrSoy-20(MS-20) to confirm its ability to improve UC severity with the treatment of standard therapies. The primary endpoint, structural alteration of gut microbiota during the trial will be analyzed. Secondary endpoints aim to observe the changes of partial Mayo score, patient response of medication of UC treatments, biomarker changes in blood, and safety after taking MS-20.

Ulcerative colitis (UC) is a persistent, idiopathic form of inflammatory bowel disease (IBD) marked by uninterrupted inflammation of the colon's mucosal lining, usually starting at the rectum and progressing proximally in a continuous manner. It manifests clinically with recurrent episodes of abdominal pain, bloody diarrhea, urgency, tenesmus, and weight loss. The precise cause of UC is still unknown; however, it is thought to arise from a multifactorial interaction involving genetic susceptibility, immune system dysregulation, disturbances in gut microbiota composition, and various environmental factors.

The goal of this exploratory, prospective, monocentric randomized crossover study is to investigate the influence of a blueberry-rich diet compared to a blueberry-poor diet on the microbiome, the intestinal barrier and the inflammatory process in IBD patients with chronic colitis. The main question the study aims to answer is: * Does a diet rich in blueberries compared to a diet low in blueberries have an influence on disease activity, intestinal inflammation and symptoms in IBD patients with chronic colitis? Ulcerative Colitis (UC) and Crohn's disease (MC) patients are recruited during an inpatient stay at the Clinic for Internal and Integrative Medicine in Bamberg, Germany. During their routine inpatient stay, patients are treated by an interdisciplinary team using a comprehensive multimodal integrative inpatient therapy concept that combines conventional medicine with a wide range of integrative non-pharmacological treatments, phytotherapy, lifestyle-modification and nutritional therapy. During this time, it is verified whether the patients can participate in the study. The study consists of two study arms, which are conducted in a cross-over design: * Intervention arm: in this study arm, participants receive 12 weeks of blueberry therapy in addition to the regular two weeks of inpatient care at the Clinic for Internal and Integrative Medicine in Bamberg. The blueberry therapy includes drinking around 35 g of blueberry powder stirred into water once a day for 12 weeks. * Control arm: in this study arm, participants receive the standard therapy (integrative medical therapy concept described above) during the regular two-week hospital stay. There is no additional blueberry intake. Due to the crossover study design, all participants undergo both study arms. This means that each participant takes the supplementary blueberry powder (intervention) for a period of 3 months and the control therapy for 3 months. The order in which the participants receive the forms of therapy is determined randomly. Thus, half of the study participants start the supplementary blueberry intake directly after the inpatient stay, the second half three months later (cross-over principle). UC and MC patients will: * initially receive a clinically indicated colonoscopy with confocal laser endomicroscopy (CLE) during their routine inpatient stay at the Clinic for Internal and Integrative Medicine in Bamberg * return to the clinic for an optional sigmoidoscopy with CLE after 12 and 24 weeks * answer questionnaires at study start as well as after 12 and 24 weeks to analyze their quality of life, the severity of their symptoms and their disease activity * give samples of blood, urine, stool and bile fluid as well as intestinal biopsies during the colonoscopy/sigmoidoscopy at study start as well as after 12 and 24 weeks * document their intake of blueberry powder as well as their symptoms and stool frequencies in a diary throughout the study participation

The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.

Inflammatory Bowel Disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, relapsing, and often disabling condition characterized by inflammation of the gastrointestinal tract. A treat-to-target strategy (T2T) is recommended by international guidelines to optimize long-term outcomes in IBD. The purpose of this study is to describe the real-life implementation of T2T in IBD worldwide and the association between using a T2T strategy and disease outcomes. This is a multi-country, observational, retrospective (non-interventional) study with a cross-sectional component based upon a sample of adult participants with IBD. All objectives will be assessed for IBD and then for CD/UC separately. Primary and secondary objectives will be assessed for the overall population over the 24 months study period. As this is an observational study, enrolled participants will be managed and followed up according to the standard practice. Retrospective chart review over the 24-months from date of inclusion will allow us to collect the variables of interest by using an e-CRF. There will be no additional burden for participants in this trial. Study visits will not be required as this is a retrospective chart review.

The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will: 1. lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life 2. affect the microbes living in the gut (gut microbiota)

Inflammatory Bowel Disease (IBD) often leads to poor disease control and reduced quality of life. Changes in the gut microbiota may disrupt the energy metabolism of immune cells, contributing to IBD. This study will examine how gut microbiota affects immune cell metabolism in healthy adults and IBD patients. Healthy volunteers will be tested before and after a short antibiotic treatment, while IBD patients will be tested once. Energy metabolism will be measured using SCENITH, a method that analyzes metabolic activity in blood immune cells. Participants will also receive a special form of fiber (13C-labeled inulin) to track how gut bacteria break down and use this nutrient. Blood, urine, and stool samples will be analyzed to follow the metabolic fate of inulin. DNA and RNA from stool will be studied to identify which bacteria metabolize the labeled fiber.

The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present. The main question this study aims to answer is: Are the newer medications used to treat IBD just as safe and effective for treating IBD in children. Participants will already be taking these newer medications as assigned by their regular health care provider.Participants' care will be managed by their regular healthcare provider as part of usual (standard) care for those with PIBD. While taking these medications, participants will be asked to answer questions about their symptoms and health periodically over the course of the study.

We attempt to examine the association between serum leucine-rich alpha-2 glycoprotein (LRG) levels and endoscopic activity in patients with possible ulcerative colitis (UC) or Crohn's disease (CD) to determine whether LRG was a predicting marker for UC or CD.

The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.

Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves. Methods Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients not declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis. Discussion Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, Quality of Life and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.

The goal of this clinical trial is to learn if MB-001, an oral biologic, is able to treat patients with ulcerative colitis. Participants will be asked to take MB-001 or a matching placebo once-daily for a period of 12 weeks. Researchers will compare MB-001 to placebo to investigate its effects on clinical symptoms as well as endoscopic and histopathological findings. Patients will be offered open-label extension for another 12 weeks following the double-blind, placebo-controlled part of the study. Participants will keep a daily diary to record their symptoms and will have up to nine clinic visits.

Patients seen at the Center for Inflammatory Bowel Disease will be asked to provide their written informed consent (authorization) to allow their identifiable medical record information related to their Inflammatory Bowel Disease to be placed in Center's Research Registry for the purpose of facilitating retrospective research studies directed at Inflammatory Bowel Disease, and the identification and recruitment of potential, eligible subjects for participation in future research studies involving Inflammatory Bowel Disease. Information obtained from the Inflammatory Bowel Disease Registry will allow a better classification of disease and factors that influence the natural course of disease; which may lead to a better understanding of the pathogenesis of IBD and may permit the development of better therapies and the potential for preventive therapies.

Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients.

It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ induction. However, the safety of UPA used in situations such as infection and tumors is inferior to that of VDZ, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy, can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe UC patients with VDZ and UPA.

The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are: 1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration. 2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity. Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod. Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration.

This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.

A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. The investigators hypothesize that some priming factors remain in the resection margin after surgery and act as a memory of the evolution of the disease, leading to the recurrence or complications. The following proposals are made: 1. defining and validating in humanized experimental models of intestinal inflammation the spatial and temporal dynamics of the postoperative complications-priming factors 2. integrating them into a machine-learning-driven model to determine risk indices of disease recurrence in IBD patients. This risk prediction model will not change the clinical decision-making process but will only be built for research. Consequently, patients enrolled in this study will be monitored and treated as per the standard of care. This project will reveal possible causes and build methods predictive of postoperative complications ultimately resulting in changes in clinical management in the near future.

The goal of this clinical trial is to learn if an app designed for diet education can help patients with inflammatory bowel disease (IBD) learn about healthy eating. The main question\[s\] it aims to answer are: * Is the app easy to use? * Is the app useful? Researchers will compare the diet app to see if it is better at teaching patients about a healthy diet than the standard information they may receive from their doctor. Participants will be asked to use the app for one month and answer surveys to see how easy the app is to use and if it leads to healthier eating.