View clinical trials related to Colitis.
Filter by:Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables to evaluate the inflammation activity of ulcerative colitis with excellent correlation with histopathology. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.
The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic Score (MCS) in adults with moderately to severely active ulcerative colitis (UC).
The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.
This is a Phase I open label study examining the efficacy and safety of TUDCA (tauroursodeoxycholic acid) in ulcerative colitis treatment.
This study is a randomized double-blind clinical trial that intends to evaluate the efficacy and safety of LGG administration at two different doses, for 1 month, in ulcerative colitis (UC) patients with mild-moderate disease activity in therapy with oral mesalamine. Efficacy of therapy will be evaluated by clinical (Clinical Mayo score, quality of life assessment), endoscopic (Endoscopic Mayo score), histological, biochemical (white cell count, C-reactive protein), and molecular (mucosal colonization of the bacteria, pro- and anti-inflammatory cytokines measurement) parameters. UC patients with mild-moderately active disease despite oral treatment with mesalamine will be assessed at baseline for clinical, endoscopic, histologic inflammatory activity. After a wash-out period of 4 weeks of mesalamine, patients will be randomized to assume a regular (LGG 1.2 × 10^10 Colony Forming Units (CFU)/day, 2 capsules a day) or a double (LGG 2.4 × 10^10 CFU/day, 4 capsules a day) dose of LGG for 1 month. At the end of the treatment, clinical, endoscopic, and histologic inflammatory activity will be evaluated and compared to pre-treatment data. Adhesion and molecular effect of LGG will be also evaluated. Safety will be assessed by weekly phone calls and with direct physical examination at the end of the study period.
This is a Phase 2, multi center, randomized, placebo controlled parallel group study to evaluate the clinical efficacy and safety of LC51 0255 in subjects with moderately to severely active ulcerative colitis
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
The purpose of the study was to assess preliminary efficacy, safety, and tolerability of LYS006 in adult patients with mild to moderate ulcerative colitis and to determine if LYS006 has an adequate clinical profile for further development in this indication.
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.
Ulcerative Colitis (UC) is an inflammatory bowel disease that can require the use of anti-TNF alpha therapy. When anti-TNF alpha failed to obtain a clinical response, the use of a new anti-integrin therapy, vedolizumab, can be proposed. The efficacy of vedolizumab has been assessed in a phase 3 study (GEMINI I), with response rates of 41.1% with vedolizumab vs 25.5% with placebo. CytoMegaloVirus (CMV) reactivation has been associated with resistance to steroid and to several lines of immunosuppressive therapy. Antiviral therapy was proven to decrease the tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in small group of patients). A recent meta-analysis supports the use of valganciclovir in case of CytoMegaloVirus (CMV) reactivation in active Ulcerative Colitis (UC). Moreover, a study showed that the risk of CMV reactivation seems to be more important with vedolizumab than with anti TNF, and the risk of colectomy is higher in case of CytoMegaloVirus (CMV) reactivation (p<0.05).