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Inflammatory Bowel Diseases clinical trials

View clinical trials related to Inflammatory Bowel Diseases.

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NCT ID: NCT03522623 Recruiting - IBD Clinical Trials

Estimating Indirect and OOP Costs in Pediatric Inflammatory Bowel Disease: a National Study

Start date: November 1, 2017
Phase:
Study type: Observational

inflammation of the gastrointestinal tract. A recent Canadian study from found that Canada has amongst highest incidence rates of childhood-onset IBD (10 per 100,000 for children <16y). In 2012, Crohn's and Colitis Canada estimated that direct medical costs of IBD in Canada were >$1 billion, and estimated indirect costs amounting to $1.8 billion. An American study demonstrated the direct costs of caring for children with IBD was double those for adults. Indirect health care costs in children with IBD have not been well-described. The Canadian Gastro-Intestinal Epidemiology Consortium (CanGIEC) is a pan-Canadian network of new and established IBD clinician-researchers and methodologists from 6 provinces experienced in the use of health administrative data. CanGIEC is evaluating variation in care of children with IBD, and will expand this research stream to assess direct and indirect cost of care. This will involve a collaboration with the CIHR/CHILD Foundation Canadian Children IBD Network (CIDsCaNN), which comprises an inception cohort of children diagnosed at all 12 pediatric IBD centres across Canada. Hypothesis: Direct health costs are dominated by medication expenses (particularly biologics), with resulting variation within and across provinces in costs and out-of-pocket expenses to the families due to coverage disparity. Indirect costs include school and parental absenteeism, and productivity losses. Aims: 1. Determine the cost of care of children with IBD, incurred by caregivers,across Canada. Costs include: a Indirect costs - costs to the patient or family related to having the disease but not to direct health care. b. Out of pocket (OOP) - costs paid in cash or credit for health-related expenses not covered by the public health or private insurance systems. 2. Determine the sociodemographic and disease characteristics associated with higher costs Methods: Population: Incident cases of IBD (<16y) over 12 months (est. enrollment 250-300). Indirect and OOP disease-related costs will be determined with surveys conducted one year following diagnosis and every 6mo for 2y. These will be conducted querying families on the preceding 4 weeks including: school and work days missed, out-of-pocket expenses, distance travelled to appointments, medications expenses incurred, and disability benefits collected. Indirect costs will be calculated using the Human Capital Approach (gross income not earned due to disease).

NCT ID: NCT03500653 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab

Start date: June 9, 2020
Phase: N/A
Study type: Interventional

Introduction: The pathogenesis of inflammatory bowel diseases (IBD) is characterized by dysregulation of the innate immune response it's associated with Th1, Th17 up-regulation, reflected by increased cytokine secretion including TNF-α. A main effective therapeutic interventions is blocking TNFα. Vedolizumab, an anti integrin, is a new class of treatment designed to block trafficking of lymphocytes in the gut. Clinical trials and real life experience response rates at week 6 range between 30-45%. Curcumin suppresses NFκβ levels via alteration of TLR2/4 pathways lowering TNF-α upstream. Curcumin is safe and efficacious in inducing response and remission in mild-moderate Ulcerative colitis (UC) and maintaining remission when used as an add-on to 5ASA derivatives, only with strict adherence to treatment overtime. Objectives: Facing the low rate of response to therapies in IBD, the need for new treatments and the use of combination strategies lead us to believe that combining vedolizumab and curcumin may have a synergistic effect and will enable optimal immunomodulation. Hypothesis: Concomitant oral curcumin in IBD patients with colonic involvement will augment remission rates as well as clinical and biochemical response. Type of research and methods of data collection: A randomized controlled trial in 84 adults with colonic IBD (UC and CD). Eligible patients are during vedolizumab induction, patients will randomized will be into curcumin or placebo. Data will managed by investigators.

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: NCT03465215 Recruiting - Crohn Disease Clinical Trials

Evaluation of Stricturing Crohn's Disease Using Digital Holographic Microscopy

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

Crohn's Disease (CD) patients, belonging to Inflammatory Bowel Disease (IBD), frequently suffer from uncontrolled intestinal inflammation. This can lead to severe disease complications requiring hospitalization. Up to 50% of all CD patients develope intestinal strictures. Intestinal strictures can be subdivided into predominantly inflammatory and predominantly fibrotic types. This subclassification in different types of strictures is important for clinical decision making: patients with predominantly fibrotic strictures would undergo surgery or interventional endoscopic treatment and patients with predominantly inflammatory strictures would be treated anti-inflammatory. To determining the degree of fibrosis and inflammation in CD strictures remains difficult. Digital holographic microscopy (DHM) is a new imaging approach belonging to the group of quantitative phase imaging. DHM enables stain-free quantitative phase contrast imaging and provides the determination of an refractive index which directly correlated to tissue density. This study aims to evaluate DHM for assessing the degree of fibrosis and inflammation in surgical specimen from patients with stricturing CD. The investigators collect full thickness surgical resection specimen from 29 patients with symptomatic CD strictures. More detailed, the investigators collect full thickness surgical resection specimen out of stenotic and non-stenotic bowel segments from each patient. For primary purposes, the investigators analyze the obtained tissue using DHM and compare differences of the refractive index, determined by DHM, between stenotic and non-stenotic parts of the intestinal wall. For secondary purposes, the investigators will correlate the findings made by DHM with a detailed analysis by a histopathologist using a scoring system (Goldstandard) to determine the degree of fibrosis and inflammation in the samples.

NCT ID: NCT03464474 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Digital Holographic Microscopy: Evaluation of Histological Disease Activity in Patients With Ulcerative Colitis

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

Ulcerative colitis (UC) belongs to the group of inflammatory bowel disease (IBD) and is characterized by a chronic relapsing disease course. As uncontrolled intestinal inflammation can lead to severe disease complications, treatment of UC has evolved from sole treatment of symptoms up to histological remission which is marked by the absence of histological inflammation. To correctly assess and quantify the degree of histological inflammation in IBD patients remains difficult. Digital holographic microscopy (DHM) is a new imaging technique belonging to quantitative phase contrast imaging. It is based on the detection of optical path-length delays in a stain-free manner, thereby providing a refractive index which directly correlates to tissue density. This study aims to evaluate the role of DHM for quantifying the degree of histological inflammation in endoscopically acquired biopsies of UC patients in a prospective clinical trial. From 28 UC patients, the investigators will obtain endoscopically acquired colonic biopsies. The investigators will assess the degree of inflammation in these biopsies using DHM and in addition to this an experienced histopathologist will determine the degree of inflammation in these biopsies using a histological scoring system (Nancy-Score = goldstandard). Finally, the investigators will directly correlate the results from DHM analysis to the histological analysis using the Nancy-Score.

NCT ID: NCT03434639 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Fluorescence Spectroscopy for Gut Permeability Assessment

GutPerm
Start date: March 29, 2019
Phase:
Study type: Observational

This research aims to develop portable devices - known as fluorescence spectrometers - to monitor the leakage of fluorescent dyes out of the gut into the blood stream. These devices will measure the leakiness (permeability) of the gut in a non-invasive manner and will provide an early warning that patients are at risk of infections caused by the unwanted flow of bacteria from the intestine to the rest of the body.

NCT ID: NCT03414580 Recruiting - Clinical trials for Inflammatory Bowel Disease

Analysis of Volatile Organic Compounds in the Exhaled Air in Inflammatory Bowel Disease

Start date: February 20, 2018
Phase:
Study type: Observational [Patient Registry]

The availability of noninvasive biomarkers for diagnosis and stratification of inflammatory bowel disease (IBD) courses is lacking. Thus, the aim of this study is to evaluated the accuracy of exhaled breath volatile metabolite analysis on diagnosis and stratification of patients with inflammatory bowel disease.

NCT ID: NCT03399188 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

Start date: November 15, 2017
Phase: N/A
Study type: Interventional

Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.

NCT ID: NCT03375424 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany

VEDOibdI
Start date: October 2, 2017
Phase: N/A
Study type: Observational [Patient Registry]

This study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease (IBD) patients in Germany extends the prospective documentation of efficacy in induction and maintenance therapy of anti-TNF to the use of Vedolizumab with a particular interest in the construction of a multifactorial model to predict long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with biologics. Little data are available on the efficacy and safety of biologics in Germany in a real world situation. While the increasing use of anti-TNF-alpha antibodies in IBD-patients the new therapy with Vedolizumab opens up new opportunities in IBD-therapy, it may also pose new options and problems in terms of efficacy and predictors of response and potential side effects.

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.