Active clinical trials for "Colitis, Ulcerative"

Recently a smartphone application IBDoc® was developed to enable patients to measure faecal calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD. Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study. They will be asked to collect a stool sample at 3 different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test cassette with an extraction device. In a second step, the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp® which is based on an immunochromatographic test. Finally, the CalApp® will transmit the test results securely to the health care professional. In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week 12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA measurements of faecal calprotectin, and the convenience of this system to the patient and the health care professional.

For both induction of remission and in maintenance of remission, different doses and treatment durations are used in practice. The aim of this study is to assess how mesalazine is used in clinical practice, at which doses and for how long and how these differences impact the patient disease state and work productivity.

This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel Disease (IBD) not already included to update the database for years 1990-2003. This will give us a truly population based study which will add to our knowledge of IBD epidemiology, allowing us to compare our rates with the rest of the world. We will be able to provide accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have special significance because of the relatively stable Monroe County population prior to 2000 (population in 1970=711,917; population in 2000 = 735,343).

The purpose of this registry is to collect information about patients in which a pouch has been created to improve in the future the quality of the surgery of the pouch.

Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.

The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in two previous studies.

Ulcerative Colitis (UC) is a disease known for repeated relapses and remissions. So, meticulous follow-up is required to individualize treatment plans according to the status of each patient. The currently used investigations are invasive, costy, and carry the risk of several side effects, making it difficult for the patient to adhere to his continuous follow-up. Aim: To evaluate the viability of fecal lactoferrin, serum ferritin, and IL6 as noninvasive markers for detecting the activity and follow-up the patients of ulcerative colitis during remission.

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).

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.

Ulcerative colitis (UC) is a chronic inflammatory condition causing continuous mucosal inflammation of the colon, which is accompanied by episodes of bloody diarrhoea and abdominal pain. Both infliximab and adalimumab have been used with success for moderate-to-severe UC refractory to conventional therapy. More recently, golimumab, another anti-TNF antibody, has been added to the treatment armamentarium. In the multi-centre, double-blind, placebo-controlled PURSUIT trial, patients with moderate-to-severe UC randomized to induction therapy with golimumab (200-100 mg, or 100-50 mg at week 0 and 2) achieved clinical response, clinical remission and mucosal healing more frequent than patients randomized to placebo. In the PURSUIT maintenance trial, patients randomized to golimumab every four weeks (100 or 50 mg) maintained clinical response through week 54 significantly more often than patients randomized to placebo. Data on the use of golimumab in daily clinical practice are unavailable. The aim of the retrospective Belgian multi-centre BE-SMART trial is to evaluate the mid-term outcome of golimumab in patients with moderate-to-severe colitis. The primary endpoint will be steroid-free golimumab continuation at week 26. Secondary endpoints will include (steroid-free) clinical remission, (steroid-free) clinical response, (steroid-free) mucosal healing, (steroid-free) complete mucosal healing hospitalization-free survival, and colectomy-free survival.