Infants With Protein Sensitive Colitis
Protein Sensitive ColitisInfants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.
A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's...
Hepatosplenic T-Cell LymphomaThis study is designed to collect tissue samples from the biopsy specimen that was used to diagnose hepatosplenic T-cell lymphoma (HSTCL), additional patient information, and if possible, to obtain additional samples including a single blood sample, a buccal swab sample and/or a bowel tissue sample. Samples obtained will be stored by the sponsor for future testing. In addition, demographic and clinical patient information will be collected. The study will be conducted in North America. Patients eligible for enrollment include males or females with IBD of any age who have a confirmed diagnosis of HSTCL. Patients will be identified through the sponsor's adverse event reporting systems. Cases reported to the sponsor's Medical Information Center will be queried to ascertain if the reporter is interested in participating in the study. Where appropriate, cases may also be identified through the sponsor's new or on-going clinical trials and registries. Samples may be collected from living patients or from stored tissue of deceased patients. This study will not restrict or introduce any therapeutic interventions, including medications. All patients will continue to be managed by their personal physicians. No healthy subjects will be enrolled in this study.
Probiotics in GastroIntestinal Disorders
Ulcerative ColitisCrohn's DiseaseAll of us have millions of bacteria living in our gut. These bacteria are very important to our health providing us with protection against infections of the gut, allowing us to gain extra nutritional value from food we eat and helping our immune system. Changes in the balance of these many bacteria can make us vulnerable to infections both from within and from outside the gut. Certain bacteria may also be directly associated with some diseases of the gut. Research by doctors and scientists into relationships between the bacteria normally found in our gut and certain diseases of the gut is helping to develop food supplements and other therapies to treat these diseases. This study involves research into the usefulness and safety of two probiotic products in maintaining remission in Crohn's disease and ulcerative colitis. Approximately 360 patients with Crohn's disease and ulcerative colitis from Ireland, Finland and Spain will be involved in the study. The yoghurts used in this study contain either Lactobacillus salivarius subsp. salivarius or Bifidobacterium infantis.
Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis
Ulcerative ColitisFollow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis Objectives: The objective of the study is to evaluate the follow up of patients treated with retarded release phosphatidylcholine in three controlled, randomized studies. Main question is to investigate whether treatment with phosphatidylcholine could spare patients the intake of steroids and immunosuppressants without clinical deterioration. Study population: Retarded release phosphatidylcholine in chronic-active ulcerative colitis. Retarded release phosphatidylcholine in steroid dependent ulcerative colitis. Dose finding study for retarded release phosphatidylcholine Outcome parameters: Definition of remission: SCCAI <2,5 Likert scale: grade 1 or 2 subjective impression of remission: yes/no no blood in stool Definition of relapse: subjective impression: yes/no SCCAI ≥ 5 blood in stool Definition of low clinical activity: SCCAI < 5 Primary endpoint: sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC. Secondary endpoints maintenance of continuous remission improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D) c.Likert Score relapse rate: a. time to first relapse b. clinical activity during relapses c. number of relapses in relation to length of treatment
A Study of Pentasa in Patients With Ulcerative Colitis
Ulcerative ColitisConfirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).
Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea...
Antibiotics Associated ColitisPulmonary InfectionAntibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is relatively infrequent in outpatients. The risk factors for AAD include broad-spectrum antibiotics, host factors (age, health status, and gender), hospitalization period and exposure to nosocomial pathogens. AAD occurs 2-8 weeks after exposure to antibiotics as a result of disrupting normal intestinal microflora. One of the roles of normal intestinal microflora is to act as a protective barrier that resists the colonization of intestinal pathogens. These patients are susceptible to infection by opportunistic pathogens without this protective barrier. Probiotic therapy is suited to AAD and Clostridium difficile disease. Probiotics assist in reestablishing the disrupted intestinal microflora, enhancing immune responses and clearing pathogens and their toxins from the host. Studies using probiotics have been reported for the past twenty-eight years (1977~2005), but the studies have been variable in trial designs and types of probiotics, had differing doses and durations of treatment, and thus have yielded controversial results. The investigators will conduct a multi-center, randomized, placebo-controlled, double-blind trial to assess the efficacy of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults.
Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis
Clostridium EnterocolitisPseudomembranous Colitis1 moreThe purpose of this study is to compare the outcome of treatment with nitazoxanide vs. vancomycin for diarrheal disease due to Clostridium difficile in patients who have failed previous treatment with metronidazole.
Response of Clostridium Difficile Infection to Metronidazole Therapy
Clostridium EnterocolitisPseudomembranous Colitis1 moreIn this record review study, our objective is to determine the rates of cure, failure and relapse following treatment of C. difficile colitis with metronidazole.
PillCam Colon Capsule Endoscopy for Ulcerative Colitis
Ulcerative ColitisPillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate patients with ulcerative colitis and reach high consistency to conventional colonoscopy.
Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment...
Ulcerative ColitisThe purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse in Chinese patients with quiescent UC.