Active clinical trials for "Inflammatory Bowel Diseases"

The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates >90%, represent a radical change from interferon-based therapies. The ECCO (European Crohn's and Colitis Organisation) guidelines (Kucharzik T, Ellul P, Greuter T, et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohn's Colitis. 2021;15(6):879-913) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence. The project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of DAAs for HCV eradication in patients with IBD. The Eneida database (Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring, and functions. Gastroenterol y Hepatol. 2020;43(9):551-8.) of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is an adequate registry to identify patients with HCV infection. The serological status of the infection is frequently recorded in the ENEIDA database, and it is generally evaluated at the time of IBD diagnosis, before starting immunosuppressive treatment. The ENEIDA registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised. This multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of HCV in patients with IBD.

Anemia is the most common extraintestinal manifestation of IBD, occurring in 6 to 74 percent of patients. Most cases of anemia in IBD are due to iron deficiency (IDA) and to anemia of inflammation (AI). Although the ECCO diagnostic criteria for IDA are simple, and iron supplementation represents a cheap and usually effective treatment, many IBD patients with IDA are not properly treated. The inconsistent adherence, by many physicians, to treatment guidelines for IDA in IBD is often motivated by the belief that mild to moderate degrees of anemia may not have a significant impact on the patient's quality of life or do not represent the main clinical problem of the patient, that oral iron supplementation may adversely affect disease activity, and that parenteral iron administration may cause severe side effects. On this basis, we aim to perform a longitudinal, prospective, observational study whose main objective is the determination of the prevalence of anemia in IBD patients in Italy. Secondary objectives of the study are a) to investigate the pathogenesis of anemia in IBD, with a particular focus on the differential diagnosis between IDA and AI, and how disease activity, extension or behavior influence the relative frequency of IDA and AI; b) to verify the adherence to ECCO guidelines for the treatment of IDA in IBD (the proportion of patients with IDA that receive adequate iron supplementation); c) to administer dedicated questionnaires to the patients in order to measure the influence of anemia on fatigue and quality of life among IBD patients.

Purpose: With the existing biologic anti-inflammatory product patents expiring and the FDA approval of new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options. This observational study will describe the patient characteristics of new users of Tumor Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic agents. It will describe in the treatment cohorts outcomes of serious infections that require hospitalization. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator anti-inflammatory biologics.

NUDT15 R139C was comfirmed to be associated with thiopurine-induced leukopenia inflammatory bowel disease (IBD) cohort.The present study aim to explor the following questions:can optimizing thiopurine dose by NUDT15 genotype reduce thiopurine-induced leucopenia?What is the influence of this optimizing strategy on clinical outcome?Thus,we conduct a randomised controlled study.Subject in the conventional group detect NUDT15 genotype before thiopurine use and optimise dosage according to the genotype.While the subjects in the control group follow the conventional monitor strategy.The primary endpoint was the rate of leukopenia.The secondary endopoint was the efficacy of thiopurine.The follow up duration was 1 year.

The digestive system may be involved in various pathologic conditions, with different inflammatory, metaplastic and neoplastic aspects. As the therapeutic tool-box for digestive diseases grows and becomes more focused, at times targeting specific molecules, decision making in managing patients becomes more and more important, and must be evidence based. Defining biomarkers with predictive value will theoretically allow physicians in making diagnosis, deciding on a suitable first line therapy (with specific endpoints suggesting response or indicating 2nd line therapy is indicated) and finally may suggest surgical intervention is warranted, thus forming an "individually tailored treatment" for each patient. These biomarkers may be located in the peripheral blood, in the gastrointestinal tract in general, or confined to specific intestinal lesions. Chitinase 3-like 1 protein (YKL-40) is produced by different tissues (e.g. - synovium, smooth muscle, intestinal epithelium). Its specific action is unknown, but several reports have described it in different inflammatory conditions including those involving the gastrointestinal system. Chitinase 3 like-1 protein (YKL-40) has also been studied for its possible role in angio and onco-genesis. This study aims to evaluate the diagnostic and prognostic value of peripheral and tissue Chitinase 3-like-1 (YKL 40) levels in gastrointestinal and liver diseases.

The purpose of this non-interventional study (NIS) study is to assess further knowledge on the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in participants with CD and UC naive to biologics.

To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies

This study has the objective to demonstrate that an education program could have a significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their disease.

Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver plays an important role in this stress-catabolism by increasing the production of urea during the inflammatory process. The purpose of this study is to examine the effect of the anti-inflammatory drugs prednisolone and infliximab on the regulation of the urea synthesis in patients with active ulcerative colitis and Crohn's disease.

Longitudinal Investigation of intestinal microbiome, fecal inflammation markers, stress and psychological variables in patients with irritable bowel syndrome and inflammatory bowel disease undergoing gut-directed hypnotherapy (GHT).