Active clinical trials for "Crohn Disease"

This study wants to address the question of whether or not oral alimentation should be begun early in patients following colorectal surgery compared to the classical diet which depends on reappearance of functional intestinal transit. Early oral alimentation following colorectal surgery may decrease hospitalisation stay duration.

Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a significant impact on growth and development. The disease is characterized by an increased and unregulated immune response. The main therapy over the last 30 years has been corticosteroids leading to remission in 50-80% of patients within 2-4 weeks. However, the use of steroids in children is limited by side-effects including acne, moon-face, hirsutism, hypertension, metabolic disturbances and above all reduced growth. Hence, pediatricians are very interested to find alternative therapies. Therapeutic manipulation of gut flora with probiotics promises to be a useful strategy for several disorders including inflammation of the gut. The efficacy of the highly concentrated probiotic VSL#3 has been documented in maintenance and prophylaxis treatment of pouchitis in double blind, placebo controlled studies in adults. The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6 mercaptopurine (MP), as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids).

The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.

Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea, respectively. Uncontrolled chronic inflammation finally causes various complications in intestine such as bowel obstruction, fistulas, abscesses, and anal fissures. The incidence of perianal fistula was reported in 13%- 39% of patients with Crohn's disease. Medical treatment for Crohn's fistulae initially focused on surgical intervention accompanied by symptomatic treatment with antibiotics and immunosuppressants. The most serious problem after surgical intervention is the relatively high incidence of postoperative anal incontinence caused by sphincter injury during the procedure. Conversely, available pharmacological therapies for Crohn's fistulae based on biologic agents such as infliximab do not generally reach ideal goal of treatment (e.g., complete closure of the fistula). A high recurrence rate after treatment with infliximab has also been reported, even after long-term maintenance therapy, which suggests that infliximab monotherapy does not provide adequate healing. The ACCENT II study demonstraded a complete fistula healing in 25% of patients. To reach a better clinical outcome, combination treatment with infliximab and surgical intervention is highly recommended for management of Crohn's fistulae. Nonetheless, even this strategy does not result in a satisfactory healing for many patients. The ideal therapeutic goal of treatment is not only complete closure of the fistula without recurrence but also preservation of anal sphincter function. Unfortunately, currently available medical or surgical treatment is not likely to offer a cure for perianal fistulae and, as noted above, recurrence is frequently reported. Together with active research in the field of bone marrow-derived mesenchymal stem cells (BM-MSCs) and hematopoietic stem cells, autologous or allogenic adipose tissue-derived stem cells (ASCs) have been studied for management of Crohn's disease and other disorders. Of particular relevance to this study, ASCs could be considered to be safe and efficacious therapeutic tools for the treatment of Crohn's fistulae. Importantly, ASCs do not cause fecal incontinence after injection into the lesion site in Crohn's disease patients. A phase I dose-escalation clinical study with ASCs manufactured by Anterogen Co., Ltd. (Seoul, Korea) demonstrated the safety and therapeutic potential of these cells for the treatment of Crohn's fistulae. A phase II study demonstrated a good rate of cronh's related fistula closure using a ASCS injection. Actually the best accepted treatment of Crohn related perianal fistula, is the surgical procedure in association whit medical therapy.

This is a randomized, double blind trial of combination therapy (Cimzia plus Azathioprine) versus mono therapy (Cimzia alone) and the improvement in mean SES-CD (Simple Endoscopic Scoring in Crohn's Disease) score. It is a trial where the investigators are administering biological therapy by itself and biological therapy plus an immunosuppressive medicine in combination to see which form of therapy has a better effect on healing ulcerations in the small intestine and colon that are due to a flare up of Crohn's disease.

This study aims to evaluate the accuracy of dual energy computerized tomography (DE-CT) in predicting the need for surgery in patients with Crohn's disease and intestinal lesions with obstructive symptoms. Patients with known Crohn's disease which were scheduled to perform abdominal CT for obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome of surgery. DE-CT parameters were then compared between patients who underwent surgery and those who did not.

Background VSL#3 has been reported as an effective adjuvant therapy both in inducing and maintaining remission in pediatric patients affected by Ulcerative Colitis. In addition, it has been shown that VSL#3 is able to modulates barrier function, intestinal permeability, and innate host functions, which if altered, could have a profound impact on the state of colitis. However it is still unclear how VSL#3-induced changes in microbial composition affect the status of intestinal inflammation and no study have investigated the efficacy of VSL#3 in the maintenance of remission in pediatric patients with Crohn's disease (CD). Objectives The purpose of this study will be to evaluate the effect of a probiotic formulation, VSL#3, versus placebo, on metabolic profile, intestinal permeability, microbiota, cytokines and chemokines expression in pediatric patients with CD in remission of disease. In addition, the efficacy of VSL#3 on the maintenance of remission will be assessed and the safety and the tolerability of the probiotic formula will be evaluated. Methods This investigation will be a prospective, multicenter, randomized, double-blind, placebo-controlled, cross-over trial. The study will include 50 children affected by CD in remission of disease, as defined by a PCDAI < 10, under treatment with Azathioprine associated or not to 5-ASA and will be articulated in 6 months as follows. All children will be randomised to a treatment group receiving for 2 months either 1-2 packet containing 900 billion bacteria/day of VSL#3 according to their weight, and a group receiving the placebo drug. Assignment to therapy or placebo will be determined according to a computer-generated randomization scheme. At the completion of the 8 weeks, a "wash-out" period of 6 weeks will be done, when no preparation will be administered. Then each patient will be switched to the other group and followed likewise for further 8 weeks. All patients will continue regular medications throughout the study period. A group of 10 volunteer healthy children, comparable in age and sex, will be used as reference group for the analysis of metabolic profile. Patients will be assessed clinically at baseline and every 8 weeks until the completion of the study, at 24 weeks or at the time of relapse. At every visit data will be collected including patient questionnaires regarding disease activity (stool frequency, stool consistency, hematochezia, abdominal pain, extraintestinal manifestations of disease, and overall patient functioning). Additional information collected at the first visit included demographic data, family history, and symptom onset. Physical examination will be performed at each visit by a paediatrician and included an abdominal examination and examination for extraintestinal manifestations of CD. Routine blood tests for CD, cellobiose/mannitol small intestinal permeability study, stool cultures, stool calprotectin, will be performed at every visit and/or at the time of relapse. Urine will be collected for the analysis of metabolic profile with mono and bi-dimensional high-resolution 1H NMR spectroscopy. PCDAI and a physician's global assessment will be used to measure disease activity. At baseline and at 24 weeks the patients will undergo ileocolonoscopy to evaluate and endoscopic and histological activity of disease. Evaluation of microbiota on biopsies and stool samples will be performed at the time of ileocolonoscopies using Fluorescence In Situ Hybridization. Colon biopsies cultures will be performed in order to evaluate cytokines and chemokines patterns by multiplex assay. Additional data will be collected during the study regarding the safety and tolerability of therapy with VSL #3. Statistical analysis will be performed using SPSS version 15 (SPSS Inc, Chicago, Illinois, USA). Variables will be screened for their distribution and appropriate parametric or non parametric tests will be adopted as required. Cross-tabulations will be evaluated by using the Fisher test and χ2test. Statistical significance will be predetermined as P < 0.05. Expected results The investigators expect to find profound alterations in metabolic profiles, intestinal permeability, microbiota, cytokines and chemokine patterns of patients affected by CD. The administration of VSL#3 is expected to ameliorate all these alterations eventually identified. From a clinical point of view the effects of VSL#3 could be translated in prolonged clinical remission maintenance, offering a new therapeutic tool in the treatment of CD.

This study compares the efficacy of early surgical with medical treatment in patients with ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up pharmacological therapy.

This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.

The goal of the study is to assess the impact of treatment with dietary supplement containing Saccharomyces boulardii (used as an addition to standard therapy), on quality of life of patients with mild forms of ulcerative colitis and Crohn disease, as well as those in remission fulfilling criteria for irritable bowel syndrome. Patients included will be randomly assigned in two groups and subsequently administered with formulation containing Saccharomyces boulardii or placebo for 4 weeks. Patient's quality of life will be assessed by questionnaire at the enrolment and 4 weeks after initiating the therapy.