View clinical trials related to Colitis, Ulcerative.
Filter by:Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.
Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and ulcerative colitis) that affect the intestines. The number of new cases of IBD in people younger than 16 years old has been increasing in the United Kingdom (UK), and is currently estimated to be 700 new cases every year. There is no cure for IBD and patients experience episodes of flareups in between periods of wellbeing. Traditionally, children with IBD are asked to attend regular hospital appointments. This means that, even if they are well, they have to get to the hospital and this can involve travelling long distances. Telephone consultations have been shown to be beneficial in some areas of medicine but this approach has not been well studied in children. The aims of this study are to determine whether telephone consultations would improve quality of life, patient satisfaction, proportion of consultations attended and whether they would be safe and reduce costs for patients and the National Health Service (NHS). Investigators plan a randomised controlled trial involving 92 participants recruited from amongst the 250 children and adolescents aged between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will be assigned to telephone consultations, and half to face to face consultations. The study would have the approval of the local ethics committee and participants would have provided written consent. Investigators will compare outcomes in the two groups over 2 years. If telephone consultations prove to be effective, the NHS could offer children with IBD the choice of either telephone consultation or face to face consultation for their outpatient followup. Those who are doing well would not have to make unnecessary journeys to the hospital. This would free up clinic spaces and allow patients who are unwell, and new patients to be seen more quickly, thus reducing waiting
The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic response to golimumab treatment in participants with moderate to severe UC who have failed on prior conventional therapies. The primary endpoints of this study are to correlate serum soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and histological activity (Geboes index) of disease.
The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.
The CIDsCaNN Network is being established with the major goals of identifying why IBD develops so commonly in children and adolescents living in Canada, and of determining the best treatment strategies for different types of IBD. Focusing on a prospective, inception cohort of Canadian children of widely varied racial origins provides a unique opportunity to explore environmental risk factors early in life and close in time to disease onset, their influence on the host microbiome, and in the context of genetic susceptibility. In keeping with current treatment targets, assessed outcomes will include not only symptom resolution and growth, but also intestinal healing. We aim to identify best practice and to institute processes for continual improvement in care nationally.
This is a Phase I, open-label, single-site trial to evaluate the drug release, using scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9] subjects will be evaluated. The subjects will receive one [1] radio-labelled tablet after a high fat and a rich in calories breakfast.
This is a Phase I, open-label, single-site trial to evaluate the drug release, using scintigraphic images and mesalazine plasma levels (PK) in healthy subjects and patients with mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of either formulation D or formulation E, respectively. Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of this new third improved formulation H. In order to keep the number of patients low, recruitment of patients will be stopped when obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will then be recruited to achieve a full set of participants (n=9 per Arm).
This is a Phase I, open-label, single-site trial to evaluate the drug release, using Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will be assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive formulation B and the second 9 subjects will receive formulation A. The subjects will be treated once with the radio-labelled study medication.
Inflammatory Bowel diseases (IBD) include Crohn's disease and ulcerative colitis. IBD's precise origin is unknown until now. Today, the current hypothesis of the disease pathogenesis is that IBD result from a dysregulated mucosal immune response to the gut microbial flora in genetically susceptible hosts. The intestinal homeostasis depends on interactions between immune and epithelial cells. Epithelial cells are the first line of defense, are tightly connected to the underlying gut associated lymphoid tissue and their alteration results in loss of tissue homeostasis. Vanin-1 (Vnn1 in mice, VNN1 in humans) is an epithelial pantheinase which regulates the cell response to stress. This ectoenzyme hydrolyses the vitamin B5-derivative pantetheine to provide cysteamine to tissues and regenerate pantothenate. Previous studies have shown that Vnn1 KO mice were more resistant to experimental colitis and administration of cystamine (oxidized form of cysteamine) restored their susceptibility to colitis. Furthermore, analysis of VNN1 expression in IBD patients show that high VNN1 expression is associated with severe clinical features. Thus, analysis of VNN1 expression could represent a good prognostic marker. In a recent published article, we characterized among a retrospective cohort of 500 IBD patients and controls new SNPs (single nucleotide polymorphisms) in the VNN1 promoter and showed their association with IBD incidence and high VNN1 expression. This suggested that the VNN1gene might be a new predisposition marker of IBD. In mouse, Vnn1 expression is tightly regulated by activation of PPARa and PPARg transcription factors. Interestingly, one of the SNPs identified in patients participates to a PPARg binding site. Interestingly, drugs related to the family of 5-ASA which are commonly used in IBD, have PPARgamma agonist potential. Therefore, quantifying VNN1 levels in patients under 5-ASA therapy might help predicting response to therapy and select patients with the highest benefit for this therapy. The purpose of this new project is to extend our initial analysis. The study will be prospective, monocentric and controlled. Its primary objective is to evaluate the level of VNN1 expression in the colonic mucosa between IBD patients and control subjects to confirm the correlation between high VNN1 expression and IBD. In relation with its prospective nature, we will also try to associate VNN1 expression level with specific endophenotypes (severity and/or localization of the lesions, quality of the response to therapy). Finally, we will screen patients for the previously identified SNPs to integrate this information in the interpretation of the results of expression analysis. This study is planned on 2 years. Two groups of patients will be constituted: one group will include IBD patients followed in the " Service de Gastro-entérologie du Pr Grimaud à l'Hôpital Nord " and the other group will constitute the control cohort including persons who were proposed a screening colonoscopy for familial history of colon cancer or polyps, or for Irritable Bowel Syndrome. The investigator will have to fill a questionnaire for each included patient, collecting information about age, sex, past medical history, taken medicine, digestive symptoms and colonoscopy indication. IBD patients will have a first set of biopsies (n = 10) and blood samples collected under general anesthesia during a colonoscopy planned in their IBD usual follow-up; a second set of similar samples will be collected within the next 12 months if an endoscopic control is medically justified. The control subjects will have only one set of biopsy and blood samples collected under general anesthesia during their colonoscopy. In the particular case of IBD patients who require surgery, a small piece of the resection will be collected ex-vivo on both healthy and pathologic areas. The blood sample will serve for quantification of the VNN1 seric pantheteinase activity and SNP's genetic study. The colonic biopsies will be obtained in duplicates from 5 different ileocolonic areas, one for histopathological analysis and the other for transcriptional analysis by qRT-PCR. The surgical samples will be used for transcriptional activity, tissue pantheteinase activity and constitution of TMA (Tissue MicroArrays) bank for immunohistochemistry. Expected benefits are to validate a new IBD prognostic marker for disease severity or potentially for evaluation of the therapeutic response.
Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double blind, placebo controlled study. The safety and efficacy of the intervention will be closely monitored.