Active clinical trials for "Inflammatory Bowel Diseases"

A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.

Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.

Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life compared to healthy adults. This is due to the chronic course of disease accompanied with diarrhea, stomach pains but also with psychological stress. It is known that physical education may improve course of disease and quality of life in a multitude of diseases. These include coronary heart disease, malignancies and also depression. The investigators believe that sport is as effective supportive tool in improving quality of life in IBD patients. But data is lacking with regard to controlled randomized clinical trials. Because of the small amount of data available the investigators considered a feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The investigators further suspect that these patients improve their quality of life compared with patients in the control group.

Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20% patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise when total body iron levels rise and protect against iron overload; conversely, in iron deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD. Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality of life and fatigue scores comparable to those seen in malignancy. IBD diagnosed in adolescence interferes with growth, education and employment as well as psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high prevalence of psychological distress, particular depression. Limited historical, and our own data suggest that children and adolescents with IBD are more anaemic than adults, and less often treated with oral iron. What is not clear is whether the apparent under-utilisation of oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns about possible side effects including worsening disease activity. To address these questions, the investigators propose a comparative study of 6 weeks of oral iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients will be given oral iron supplementation. Before and after iron therapy, the investigators shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived stress, mood and fatigue; iron metabolism, including serum hepcidin.

Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy of mangoes has not previously been compared with respect to mild inflammatory bowel disease. In order to justify future pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step. Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would have a significant impact on public health.

In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has not responded to conventional therapies. The goals of this study are to test the safety and tolerability of donor mesenchymal stromal cells in children with Inflammatory Bowel Disease. Mesenchymal stromal cells support the development of blood cells within the bone marrow. When isolated from a donor and infused into an animal or human, they have been demonstrated to travel to areas of inflammation, to alter immune responses, to decrease pro-inflammatory cytokines, and to promote tissue repair. Infusion of these cells does not lead to rejection. These properties lead investigators to hypothesize that that these may be they may be beneficial in treating inflammatory bowel disease.

This is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16 sites in Bulgaria, Germany and Romania. A total of ca. 30 - 35 patients will receive SC12267 (4SC-101) tablets, 35 mg once daily for 12 weeks. First of all the patients will undergo a screening period of 1 week and a follow-up visit will be performed 4 weeks after study drug discontinuation or earlier in case of relapse during follow up. Total study duration will be up to 36 (+2) weeks. There will be 8 study visits: one screening visit, 6 visits during the treatment period and one follow-up visit. In addition, four telephone visits will be performed at Week 6, Week 10, Week 20 (+1) and Week 36 (+2). The duration of the entire study (first patient in till last patient out) is expected to be about 13 months.

Main Study Objectives: The study is conducted to evaluate the minimal allopurinol and azathioprine doses that, in combination, produce therapeutic 6-TGN levels evaluate the safety and tolerability of the different allopurinol/azathioprine dose levels assess if concomitant allopurinol affects TPMT activity assess the clinical efficacy of concomitant allopurinol-azathioprine therapy in the included patients

This is a single center, open label forced dose titration study designed to determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease (IBD). This study will provide initial tolerability and safety data in pediatric patients with IBD. Twenty patients with IBD in remission or with mild disease (score <34 on PUCAI or score <30 on the PCDAI) on sulfasalazine or mesalamine aged 8 to 18 years will be enrolled into this study. Each patient will participate in the study for nine weeks. From this study an appropriate dosage will be determined to proceed with a double blinded placebo controlled study.

GSK1070806 is a humanised monoclonal antibody that blocks a protein present in the body called Interleukin-18. The main purpose of this study is to test GSK1070806 in healthy and obese male subjects with normal immune systems to find out how safe this drug is and how long the body takes to get rid of it. The study consists of 2 parts. Part 1 will consist of 6 groups of healthy male subjects and Part 2 will consist of 3 groups of obese male subjects. A total of 89 subjects is planned for this study. Subjects in each group will receive one dose of the study drug or placebo. Dosing in Part 2 will not start until dosing of the first 4 groups is completed in Part 1 and the preliminary safety and pharmacokinetic data from these 4 groups in Part 1 has been reviewed. Both parts will be conducted single-blind and with a placebo control. Within each group, allocation of subjects to placebo or active treatment (GSK1070806) will be randomised.