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Ulcerative Colitis clinical trials

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NCT ID: NCT05931458 Not yet recruiting - Ulcerative Colitis Clinical Trials

AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis

ADVANCED-UC
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease (IBD) characterized by a multifactorial etiology, a variable involvement of large bowel, and a relapsing-remitting course. In order to keep the disease in a "quiescent" status and to prevent relapses, a significative percentage of UC patients will remain on long-term drug therapy. However, long-term immunosuppressant therapy is not free of risks and complications: in fact, these therapies have an impact on both healthcare system resources and patients' quality of life; more, there are even concerns regarding the side effects of long-term immunosuppressant therapy. Over the past 20 years, a considerable amount of evidence was produced to support the immunomodulatory role of the appendix in the development and course of UC: there is a strong inverse relationship between previous appendectomy and development of the UC. One of the proposed theories to justify this link is that the appendix could act as a reservoir for commensal bacteria that can be secreted into the colon, affecting its microbiome and immunological response; another theory describes the appendix as the "priming site" for the cytokine production and the immunological cascade that may trigger inflammation in colon and rectum. The idea of this study moves from these assumptions: the investigators aim to evaluate the impact of appendectomy in patients with UC who are candidates to the treatment with biologics (Anti TNF-a), because of conventional therapies failure. To further reduce any ethical problems and significantly lower any surgical morbidity, investigators will restrict the study population to only patients with active left-sided colitis, so that the surgery for appendectomy will take place on a non-inflamed cecum. By undertaking this study, the investigators hope to a) learn more about the role of appendix and the impact of appendectomy in the clinical history of Ulcerative Colitis; b) demonstrate that laparoscopic appendectomy, a relatively simple surgical procedure that can also be performed in day-surgery with a very low expected complication rate, is a treatment that is superior to biological therapy, avoiding patients starting a chronic, long-lasting therapy, with the consequent risk of immunosuppression, and with possible higher costs for the health system in the long term.

NCT ID: NCT05907330 Not yet recruiting - Ulcerative Colitis Clinical Trials

Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis

UC
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The study is designed to investigate efficacy and safety of CU104 in patients with moderate to severe ulcerative colitis.

NCT ID: NCT05892159 Not yet recruiting - Ulcerative Colitis Clinical Trials

Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

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

This is a prospective interventional study exploring the modifiability of physiological metrics, namely Heart Rate Variability (HRV), using a 5-week standardized HRV biofeedback intervention in subjects with symptomatic ulcerative colitis. Participants will be followed for 17 weeks. The goal is the understand if modifying these markers can impact ulcerative colitis related symptoms.

NCT ID: NCT05835973 Not yet recruiting - Ulcerative Colitis Clinical Trials

Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.

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

Inflammatory Bowel Diseases (IBD) go through two phases: flare and remission. Prediction of flares and identification of patients in remission but at high risk of flare are a major issue when taking care of IBD patients. Considering close interactions between sleep, immunity and intestinal inflammation, sleep disorders could be a predictor of flares. The purpose of this study is to demonstrate that sleep efficacy decreases before IBD flare. Patients in remission will be assessed for IBD symptoms (activity scores, biological factors) and sleep disorders (actigraphy, DREEM®, questionnaires) during one year.

NCT ID: NCT05809583 Not yet recruiting - Ulcerative Colitis Clinical Trials

Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis

Start date: May 1, 2023
Phase:
Study type: Observational

A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.

NCT ID: NCT05771155 Not yet recruiting - Ulcerative Colitis Clinical Trials

Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®

UCESIVE
Start date: May 2023
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, parallel arm, double-blind study with approximately 750 participants with moderately to severely active Colitis Ulcerosa randomized to receive either PB016 or Entyvio®

NCT ID: NCT05743153 Not yet recruiting - Ulcerative Colitis Clinical Trials

Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis

OPTIMIZE-UC
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in Ulcerative Colitis (UC) patients with active disease as well as in patients in remission. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes.

NCT ID: NCT05737836 Not yet recruiting - Ulcerative Colitis Clinical Trials

Analyzing the Factors in Ulcerative Colitis Patients' Clinical Trial Experiences

Start date: March 2024
Phase:
Study type: Observational

Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. This study will admit a wide range of data on the clinical trial experience of Ulcerative Colitis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Ulcerative Colitis patients.

NCT ID: NCT05719766 Not yet recruiting - Ulcerative Colitis Clinical Trials

Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This study aims to prospectively explore the effect of incentive-integrated E-IBD (electronic inflammatory bowel disease) chronic disease management model on the improvement of IBD quality of life, and provide a more effective chronic disease management model for improving the quality of life and social participation of IBD patients.The investigators firstly identify the IBD patients in need of empowerment disease activities through the questionnaire .Then, the investigators feedback the patients' education content according to their needs found.Based on the social support network of patient organization and the medical support network of tertiary medical institutions, the investigators complete the empowerment process of IBD patients' self-management initiative and self-management ability, through the internet. Finally ,the investigators evaluate the quality of life(QoL), social participation,disease self-management level via questionnaire . The primary outcome is the improvement of QoL score after three months' intervention.

NCT ID: NCT05715099 Not yet recruiting - Ulcerative Colitis Clinical Trials

Saffron as Anti Inflammatory In Patients With Inflammatory Bowel Disease

Start date: March 30, 2023
Phase: Phase 4
Study type: Interventional

Nutritional Saffron supplement has been widely used as food supplement and has known anti-depressant and anti-inflammatory activities. The investigators use saffron extract in Egyptian patients with ulcerative colitis for 8 weeks.