View clinical trials related to Inflammatory Bowel Diseases.
Filter by:The purpose of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric participants with inflammatory bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above the currently approved dose [5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)] and the safety of that dose escalation.
Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing endoscopy. The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease. The study protocol is based on comparing imaging findings of p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of inflammatory bowel disease. CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment.
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC) which peak in incidence (rate or frequency) during the reproductive years. An increasing number of young people will face challenging decisions regarding medical management of this chronic disease during a period of time when they are still completing schooling, establishing their career, and/or are building a family. Treatment options for IBD consist of immunosuppressive therapy, such as immunomodulators (azathioprine and methotrexate). Methotrexate (MTX) is a folic acid antagonist (a substance that interferes with or inhibits the action of another). It is thought that MTX works by decreasing the inflammation in the gastrointestinal tract. MTX has been studied for many years and in used as treatment in not only IBD, but also in conditions such as rheumatoid arthritis and lupus. However, due to concerns about the safety of MTX, particularly in regards to fertility and pregnancy has limited its current use. Participants are invited to take part in this research project to determine whether the treatment of IBD patients with MTX is associated with an increased risk for infertility. Investigators will recruit 75 male IBD patients under MTX treatment for their IBD as well as 75 healthy male controls for a total of 150 patients at the University of Wisconsin Hospital & Clinics.
The immunogenicity of anti-tumor necrosis factor alpha (anti-TNF) therapy in inflammatory bowel disease (IBD) is an important cause of loss of response to therapy that may lead to escalation of dose or discontinuation of therapy. Antibodies may develop to infliximab (ATI) or to adalimumab (ATA) and cause this loss of response, also known as a secondary loss of response. An alternative approach is the addition of immunomodulator (IM) therapy to counteract the antibody response and regain efficacy of the biologic medication. The investigators' goal is to treat patients' who have lost response to adalimumab or infliximab with an immunomodulator with the goal of eliminating the circulating antibodies to the anti-TNF and restoring efficacy.
Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.
Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy intestine as a probiotic preparation. The feces of a healthy individual is fluidized and than inserted into the intestinal tract of a sick individual, assuming that the healthy flora will colonize and cure the intestine. There are reports of the efficacy of this treatment for inflammatory bowel disease but currently the numbers are small. aim: To investigate whether use of FMT will bring improvement for colitis in IBD patients . Methods: The patients will undergo full colonoscopy, the stool preparation will be infused through the colonoscope during withdrawal of the instrument.
This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is much weaker than in the general population. There are two types of anti-pneumococcal vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate, Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of PSV-23® after an interval of two months. In the case of young children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients. Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine, PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We also want to evaluate the immunological impact of these different strategies in their capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim, we are studying all immunological functional aspects of the antibodies and B lymphocytes induced by the two vaccine strategies.
This study aims to determine the prevalence of HBV infection in patients with IBD and rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load and clinical course of IBD patients.
The small bowel is poorly suited to standard endoscopy techniques due to its anatomical differences from the colon and the upper gastrointestinal tract. The small bowel has an average length of 6.7 m, with a free mesentery that resists standard "push to advance" endoscopy techniques. New developments in overtubes, which are placed over an enteroscope, have revolutionized doctors ability to deeply intubate the small bowel. Three types of 'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE), have been developed. Although studies have been performed on these individual techniques, there are no studies comparing SBE and SE, the two techniques used in Johns Hopkins. The investigators propose performing a prospective, randomised trial, to assess the differences between these two techniques. The question of what differences there are between these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields, time required for the procedure and the sedation requirements, are important questions to answer, and depending on the results, would affect the investigators approach to patients with small bowel disease.
Background: - Bone marrow stromal cells (BMSCs) are cells that can develop into other tissue types, including bone, cartilage, marrow, and blood cells. However, BMSCs are not stem cells there is no evidence that after infusion into another person that BMSCs change into any other cells. Research suggests that BMSCs can travel to different parts of the body and work with immune cells to reduce inflammation and help repair damaged tissues. BMSC infusions have been used in tests to treat moderate to severe inflammatory bowel disease, like Crohn's disease (CD) or ulcerative colitis (UC). These tests have shown some good results, but more research is needed to study their safety and effectiveness. Researchers want to see how well BMSC infusions work to treat CD and UC. The BMSCs will be collected from volunteer donors. Objectives: - To look at the safety and effectiveness of BMSC infusions for moderate to severe CD and UC. Eligibility: - Individuals between 18 and 65 years old with moderate or severe inflammatory bowel disease (CD or UC) that has not responded to standard treatment. Design: - Participants will have two screening visits. The first will be 15 to 30 days before the first BMSC infusion. The second will be within 14 days of the first BMSC infusion. - At the first screening visit, participants will have a physical exam and medical history. They will provide blood, urine, and stool samples. They will also give information about their symptoms and quality of life. - At the second screening visit, participants will have their vital signs (like blood pressure and heart rate) measured. They will also provide blood samples, and have a colonoscopy with biopsies. - During treatment, participants will have one BMSC infusion per week for 4 weeks. Blood and urine samples will be collected at each treatment visit. - One week after the last infusion, participants will have a study visit. The tests from the first and second screening visits will be repeated. - There will be six follow-up visits at 1, 2, 3, 6, 12, and 24 months after the last study visit. Participants will repeat the tests from the first screening visit.