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BI 655130 Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are - to prove the concept of clinical activity of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) - to confirm efficacy and safety of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) - To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020,...
18 Years - 75 YearsLearn More -
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
To evaluate the long-term safety of BI 655130 in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials
18 Years and OverLearn More -
Bowel Preparation for Magnetic Resonance Enterography
Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. We present the design of randomized controlled trial to compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking contrast orally for MRE in patients with Crohn's disease (CD).
14 Years and OverLearn More -
Budesonide for Induction of Remission in Incomplete Microscopic Colitis
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
18 Years - 80 YearsLearn More -
Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients
Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is common, particularly among Crohn's patients who had a small bowel resection. This patient population experiences a lifetime occurrence of kidney stone formation as high as 25% accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium. This study's...
19 Years and OverLearn More -
Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease
To date, few studies have assessed the efficacy and safety of Cannabinoids, compounds derived from the Cannabis plant, in patients with Crohn's disease. Our study seeks to pilot a randomized, placebo-controlled trial assessing the efficacy and safety of oral cannabinoids as an adjunct therapy in patients with Crohn's disease.
18 Years and OverLearn More -
Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy?
There are around 115,000 people in the United Kingdom suffering with Crohn's Disease (CD). CD can cause inflammation and ulcers to develop anywhere within the gut. Symptoms of the disease include diarrhoea, abdominal pain and nutritional problems including vitamin D deficiency. Around half of people with CD are likely to have vitamin D deficiency. Research has shown that treating vitamin D deficiency in people with CD might help to improve the symptoms of the disease. However, there are no clear guidelines on how to detect or treat vitamin D deficiency in people with CD. There will be two parts to the planned research involving three...
18 Years and OverLearn More -
Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
Aims: - To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD). - To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing. - To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy. - To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy. Project design: Cross sectional, prospective, comparative study Methodology: Patients...
18 Years - 75 YearsLearn More -
Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients
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 pediatric patients with mild-moderate UC. The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation, in newly diagnosed pediatric patients with mild-moderate UC. All processing will occur at...
12 Years - 18 YearsLearn More -
C. Difficile and Ursodiol
In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid composition (80% deoxycholic acid) to maintain growth suppression.
18 Years and OverLearn More
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