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Colitis, Ulcerative clinical trials

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NCT ID: NCT06420492 Not yet recruiting - Ulcerative Colitis Clinical Trials

Study of Novel Therapeutics for Acute Remedy of Colitis

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

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.

NCT ID: NCT06420375 Not yet recruiting - Ulcerative Colitis Clinical Trials

Treatment of UC With Novel Therapeutics

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

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with active mild ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as a crossover study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study.

NCT ID: NCT06405087 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Start date: December 2, 2024
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT06398626 Not yet recruiting - Colitis, Ulcerative Clinical Trials

An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

ENDEAVOUR-UC
Start date: May 15, 2024
Phase:
Study type: Observational

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod. All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer. The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.

NCT ID: NCT06352515 Not yet recruiting - Ulcerative Colitis Clinical Trials

T Lymphocyte Subsets in Ulcerative Colitis

Start date: June 1, 2024
Phase:
Study type: Observational

1. Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients. 2. Correlation of T-cell subsets to therapeutic response/ disease activity. 3. Assess the value of circulating IgG anti-Integrin αvβ6 in UC.

NCT ID: NCT06338930 Not yet recruiting - Crohn Disease Clinical Trials

Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy

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

Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. However, many of these patients do not require additional interventions from the IBD specialist during these visits. In addition, patients in long-term remission, often request a less frequent follow-up in the hospital and in consequence a less frequent absence from school or work. In conclusion, these routinely follow-up visits might put unnecessary burden on both healthcare providers and IBD patients, as well as on healthcare resources. Until now, no clear standard was set for how to organize a remote monitoring programme that is feasible and safe in a large patient population. Despite the possible added value of remote monitoring for IBD patients on stable or no therapy and who are in remission, they are seldomly the targeted population in clinical trials analysing the effects of remote monitoring in IBD. Secondly, a significant reduction in outpatient clinic visits, is often not actively included in the programme, but more an outcome result. Finally, to compose a safe remote monitoring programme, subjective and objective parameters of disease activity should be collected. With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags.

NCT ID: NCT06335160 Not yet recruiting - Ulcerative Colitis Clinical Trials

Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine

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

To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine

NCT ID: NCT06331637 Not yet recruiting - Ulcerative Colitis Clinical Trials

Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis

TTSS-Pouch
Start date: July 31, 2024
Phase:
Study type: Observational

This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)

NCT ID: NCT06306261 Not yet recruiting - Ulcerative Colitis Clinical Trials

Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis

TIMAEUS
Start date: March 15, 2024
Phase:
Study type: Observational

The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.

NCT ID: NCT06298461 Not yet recruiting - Ulcerative Colitis Clinical Trials

Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.

Start date: May 2024
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).