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Ulcerative Colitis clinical trials

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NCT ID: NCT03536988 Recruiting - Ulcerative Colitis Clinical Trials

TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

Start date: April 12, 2018
Phase: N/A
Study type: Interventional

The objective of this RCT is to compare the postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.

NCT ID: NCT03519945 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

Start date: July 18, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.

NCT ID: NCT03504930 Recruiting - Ulcerative Colitis Clinical Trials

COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity.

COLISURG
Start date: June 7, 2018
Phase:
Study type: Observational

The surgical treatment of the ulcerative colitis (UC) remains associate to a significant morbidity (up to 60%). Anastomotic fistula and pelvic sepsis are the most severe complications which could dramatically compromise the surgical issue and functional status. Thanks to the current therapeutic arsenal and the evolution of health care paradigms, the quality of life of patients plays a key role in the modern global management of these medical conditions. Biotherapies (e.g anti-TNF) are widely used to treat patients with UC. Anti-TNF and anti-integrins have an effect on the immune response and can theoretically aggravate the infectious disease. Their potential impact on postoperative complications after ileo anal anastomosis (AIA) remains debated. Very few studies have looked at other biotherapies including vedolizumab. All studies are retrospective series with small sample size. Here again the conclusion remain contradictory. Lightner et al. showed an increased risk of surgical site infection for patients preoperatively exposed to vedolizumab (37% vs. 10%, p <0.001). In a dedicated cohort to the RCH, the same author found a risk of increased pelvic abscess (31.3% vs 5.9%, NS) but the difference was not statistically significant probably for lack of power. Other studies did not find any impact of vedolizumab on the risk of postoperative complications. To clearly determine within a large prospective cohort the impact of anti-TNF agents and biotherapies on the postoperative complications seems to be essential in order to adapt and to optimize the therapeutic strategy, especially the surgical sequences, in patients with UCR whom benefit a surgery.

NCT ID: NCT03483246 Recruiting - Ulcerative Colitis Clinical Trials

Impact of Fecal Microbiota Transplantation in Ulcerative Colitis

REBALANCE-UC
Start date: September 17, 2018
Phase: Phase 3
Study type: Interventional

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. UC pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts. The purpose of this study is to determine the effect of the fecal microbiota transplantation on UC.

NCT ID: NCT03477032 Recruiting - Ulcerative Colitis Clinical Trials

FMT in Inflammatory Bowel Disease

Start date: June 1, 2018
Phase:
Study type: Observational

This is a prospective observational cohort study, over 52 weeks, evaluating the the use of faecal microbiota transplantation amongst patients with Inflammatory Bowel Disease and Microscopic Colitis

NCT ID: NCT03394586 Recruiting - Ulcerative Colitis Clinical Trials

Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab

Start date: January 1, 2018
Phase: N/A
Study type: Observational [Patient Registry]

TNF inhibitors have improved treatment options for patients with inflammatory bowel disease (IBD) and three TNF inhibitors, infliximab, adalimumab and golimumab are available for treatment of ulcerative colitis in Switzerland. However, these drugs have been tested under ideal conditions in randomized controlled trials. Real-world data are needed to complement this information. It is the aim of our study to test, whether patients with ulcerative colitis can be effectively treated with golimumab in a real world setting in Switzerland. The investigators will use data from the Swiss IBD cohort study (SIBDC) in Switzerland. They will identify all SIBDC patients with UC treated with Golimumab and perform a retrospective chart review. The investigators will acquire patient reported outcomes and objective measures for inflammation at baseline, at 6-10 weeks and at 6 and 12 months after golimumab treatment. Primary endpoint will be clinical response (i.e. meaningful improvement) at 6-10 weeks. Secondary endpoints will be clinical response at 6 and 12 months and clinical remission (i.e. free of symptoms of disease).

NCT ID: NCT03366090 Recruiting - Ulcerative Colitis Clinical Trials

Immunological Profiles in Inflammatory Bowel Disease

ImmunoIBD
Start date: October 1, 2017
Phase: N/A
Study type: Observational

Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.

NCT ID: NCT03327038 Recruiting - Depression Clinical Trials

Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Inflammatory Bowel Diseases (IBD) are chronic debilitating disorders of the gastrointestinal tract that comprise two subtypes; Crohn's Disease (CD) and Ulcerative Colitis (UC). Canada has among the highest incidence rates of CD and UC in the world, as high as 20.2 and 19.5 per 100,000 respectively. Although, IBD can occur at any age, it is frequently diagnosed in the second and third decades of life, at a time when vulnerable individuals are entering the prime years of their lives. This age of onset, coupled with the recurrent and frequently relapsing nature of these disorders, can significantly impair the psychological well-being of patients. Therefore, it's not surprising that patients with IBD report a higher burden of depression and anxiety in comparison to the general population. The prevalence of depression and anxiety in patients with IBD have previously been linked to the following: (1) Increased risk of surgery; (2) Increased number of relapses; (3) Clinical recurrence; (4) Treatment failure and earlier retreatment; (5) Lower self-reported quality of life, satisfaction, and medication adherence; (6) and Increased health care utilization. Although, depression and anxiety are highly treatable conditions, they are often under-recognized and under- treated in patients with IBD. The most common treatments for these disorders are pharmacological agents and psychological treatments. Psychological treatments like Cognitive Behavioral Therapy (CBT) have extensive support for treatment of depression and anxiety. The major advantage of psychological treatments over pharmacological agents is their ability to sustain improved depression and anxiety symptoms in patients post-treatment. As part of this study, we aim to evaluate the following: Specific Aim #1: Determine whether a psychological intervention, involving web-based CBT, is effective in ameliorating depression and anxiety symptoms in a cohort of adult IBD patients. Specific Aim #2: Determine the durability effect of the intervention on sustaining improved psychiatric symptoms. Specific Aim #3: Determine the impact of a psychological on IBD-specific and psychiatric-specific health care utilization.

NCT ID: NCT03273465 Recruiting - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation in Ulcerative Colitis

Start date: March 27, 2017
Phase: Phase 2
Study type: Interventional

Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis. This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed adult patients with mild-moderate UC. The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation,in newly diagnosed adult patients with mild-moderate UC. All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.

NCT ID: NCT03257345 Recruiting - Ulcerative Colitis Clinical Trials

VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease

VEST
Start date: February 3, 2017
Phase:
Study type: Observational [Patient Registry]

Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's disease. The aim of this study is to capture the early real life UK experience of vedolizumab including the outcomes of treatment, describing the patient population treated, drug persistence, IBD control PROM, durable remission, tolerance and safety.