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Intestinal Diseases clinical trials

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NCT ID: NCT04123990 Not yet recruiting - Intestinal Disease Clinical Trials

Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease

Start date: November 2, 2019
Phase: N/A
Study type: Interventional

Despite its known prevalence in IBD, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was an under-diagnosed and under-treated co-morbidity. In chronic diseases including IBD, Transferrin Saturation Factor is only performed in approximately 10% of cases, whereas it is recommended in inflammatory situations including IBD patients (HAS 2011). The objective of this study is therefore to obtain updated French data on the prevalence of iron deficiency in patients with IBD by applying the recommendations of ECCO and French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor)

NCT ID: NCT04109300 Not yet recruiting - Ulcerative Colitis Clinical Trials

Preemptive HLA Genotyping for the Safe Use of Infliximab-combination Therapy in Inflammatory Bowel Disease

INHERIT
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Inflammatory bowel disease (IBD) is a common disease in Canada, leading to significant morbidity as a result of remitting and relapsing intestinal inflammation. Currently, tumor necrosis factor (TNF) antagonists such as infliximab, make up 30% of the biologic agents available to individuals with IBD. There is a high risk of losing response or having a hypersensitivity reaction to infliximab, necessitating treatment discontinuation. This is due, in part, to the formation of anti-drug antibodies (ADAs). ADA formation can result in loss of response to therapy which may eliminate an intestine-saving therapy and increases their risk of progressing to surgical resection. There are few tools clinicians can implement to minimize the risk of ADA formation. The current approach is to add a second drug (known as combination therapy), specifically an immunomodulator (methotrexate or azathioprine), exposing the patient to additional medication-related risks, intensive monitoring with bi-weekly blood work and potential side effects including infection and malignancy. Preliminary data from our group as well as others suggests that individuals who carry a variant in the class 2 human leukocyte antigen (HLA) gene (HLADQA1*05A>G, rs2097432) are more likely to form ADAs to infliximab. Pre-emptive screening for this variant may allow clinicians to more selectively use combination therapy, recommending it only in IBD patients at high risk of developing ADAs to infliximab. Additionally, this may result in fewer drug-associated adverse events. With this project, we aim to explore the value of prospective HLADQA1*05 screening (pharmacogenomic screening) in IBD patients being considered for treatment with infliximab and using the result to guide the application of combination therapy compared to IBD patients treated with infliximab (with or without a second agent) as per current practice. We will assess the incidence of infliximab ADA formation, as well as the incidence of infliximab loss of response, treatment discontinuation, and adverse drug events. Additionally, we will assess the time to each of these events.

NCT ID: NCT04105348 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Diabetes Mellitus and Inflammatory Bowel Disease

Start date: October 1, 2019
Phase:
Study type: Observational

Diabetes mellitus is a hyperglycemic metabolic disorder due to insulin deficiency or resistance at its receptors, leads to impaired glucose metabolism and multi-organ affection; (optic, peripheral neurological, cardiovascular and renal).

NCT ID: NCT04067934 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

JUMP Inflammatory Bowel Disease Study

JUMP IBD
Start date: August 2019
Phase: N/A
Study type: Interventional

Children and adolescents with inflammatory bowel disease are at increased risk of poor bone and muscle health through a variety of factors, including underlying disease processes, nutritional deficits, and reduced physical activity. Inflammatory bowel disease can also delay the onset of puberty in children, and pubertal development in adolescents, resulting in sub-optimal adult bone mass, therefore increasing future risk of fractures and osteoporosis. High impact exercise may be a useful additional therapy for adolescents with IBD, as the mechanical strains produced during this type of exercise, through high force muscular contractions and ground reaction forces, can promote bone formation and gains in muscle mass. There have been no previous studies assessing the effects of high impact exercise in IBD, so it is unknown if this type of exercise is feasible in this population. The aim of this study is to assess the feasibility of a short term jumping based exercise intervention for improving muscle and bone outcomes in children and adolescents with inflammatory bowel disease.

NCT ID: NCT04031482 Not yet recruiting - Ulcerative Colitis Clinical Trials

TARGET Registry A Project of the German Network for Intestinal Diseases in Cooperation With Other Corporate Partners

TARGET
Start date: October 2019
Phase:
Study type: Observational [Patient Registry]

By capturing possible or known risk factors, it will be possible to recognize connections between these risk factors and the disease, thus obtaining valuable insights into the cause of the disease. This in turn facilitates an improved evaluation of the treatment situation as well as influencing future framework conditions for preventive measures and planning treatments. Disease registries are thus crucial for the planning and structuring of health policies. The present registry protocol serves as a basis for the proper implementation of a registry for patients with chronic inflammatory bowel diseases. It describes the study rationale, objectives, design, participant groups, procedures and evaluation methods. Furthermore, it defines the responsibilities of each person involved in maintaining the registry and also forms the basis for decisions regarding evaluation by the Ethics Committee.

NCT ID: NCT03885479 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Impact of Different Dietary IgGs on the Pathogenesis of IBD

Start date: April 1, 2019
Phase:
Study type: Observational

Identify the association between certain food IgGs (Wheat, rice, broad beans, cow milk, eggs, chicken and beef) and the immunological response in patients with IBD

NCT ID: NCT03868332 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Predictors of Subclinical Atherosclerotic Cardiovascular Diseases (ASCVD) in Patients With Inflammatory Bowel Disease

Start date: July 20, 2019
Phase:
Study type: Observational

Heart disease and failure are the major causes of mortality and morbidity worldwide, despite significant advances in medical technologies in the diagnosis and treatment of the disease. Cardiovascular disease may arise for various reasons including the steadily increasing incidence of obesity, type 2 diabetes, genetic, environmental, dietary and lifestyle factors. Besides all these, there is much evidence suggetsing that inflammation is an important player in the pathogenesis of heart disease, as well as atherogenesis and atherosclerosis.

NCT ID: NCT03843697 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

A Trial for Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Trial for IBD patients non-responsive to biological drugs, using medical app reminding patients to take their physician-prescribed medications

NCT ID: NCT03833310 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Novel Biomarkers in Inflammatory Bowel Disease

Start date: January 1, 2021
Phase:
Study type: Observational

The inflammatory bowel diseases represent a heterogeneous group of chronic , relapsing- inflammatory disorders of the gastrointestinal tract. Crohn's disease and ulcerative colitis are the two major clinical forms.The global incidence and prevalence of the inflammatory bowel diseases has increased over the last 2-4 decades . Despite the great progress in understanding the pathogenesis of these diseases, their etiology remains unclear . Considerable effort has been devoted to the development of an accurate ,noninvasive biomarkers that have increased diagnostic sensitivity and specificity . Osteoprotegerin is a member of the Tumor Necrosis Factor Receptor superfamily of proteins. Osteoprotegerin is of particular importance in bone metabolism, inflammation , tumorigenesis, and other processes where cell differentiation, survival, and death are controlled. Osteoprotegerin activates inflammation in the gut by stimulating immune cells, cytokines, and the Necrosis factor-κappaB pathway . Soluble Receptor activator of nuclear factor kappa-Β ligand is known as a type II membrane protein and as a member of tumor necrosis factor superfamily . Soluble Receptor activator of nuclear factor kappa-Β ligand has been identified to affect the immune system and a binding partner of ( Osteoprotegerin ), and controls cell proliferation.The interactions between Osteoprotegerin and Soluble Receptor activator of nuclear factor kappa-Β ligand, Soluble Receptor activator of nuclear factor kappa-Β have relevance to inflammatory pathways. Soluble Receptor activator of nuclear factor kappa-Β ligand- Soluble Receptor activator of nuclear factor kappa-Β ligand binding activates pathways that contribute to the survival of T-lymphocytes and dendritic cells .

NCT ID: NCT03486652 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Rheumatological Manifestations in Inflammatory Bowel Diseases

Start date: May 1, 2018
Phase:
Study type: Observational

IBD-related arthropathy is one of a group of inflammatory arthritides considered as seronegative spondyloarthropathies, a group of disorders that also includes ankylosing spondylitis, psoriatic arthritis, reactive arthritis, and undifferentiated SpA. IBD-related SpA is mainly characterized by axial involvement but may also be associated with peripheral symptoms, such as synovitis, dactylitis, or enthesitis