Dietary Treatment of Crohn's Disease
Crohn's DiseaseInflammatory Bowel DiseaseOur objective is to determine whether a specific dietary intervention or a fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohn's Disease (CD.
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease...
Crohn DiseaseThe primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].
Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease...
Crohn's DiseaseThis study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is most effective in treating active moderate Crohn's disease. Rifaximin tablets are already marketed in some European countries and the USA to treat traveller's diarrhoea. A new gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver Rifaximin directly to the site of the disease. Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.
Atorvastatin in Moderate Active Crohns Disease
Crohns DiseaseOpen pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease.
Phase II Study of RR110 in Patients With Active Crohn's Disease
Crohn's DiseaseThe purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy...
Crohn's DiseaseUlcerative Colitis5 moreThe purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease
Crohn DiseaseThe purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in patients with active Crohn's disease.
Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease
Crohn's DiseaseThe purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat Crohn's disease in patients with at least one perianal fistula. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 17 month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work. Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).
The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease
Crohn's DiseaseThis study will test whether a new experimental drug called STA-5326 mesylate will decrease inflammatory chemicals called cytokines in patients with Crohn's disease. The drug has prevented gut inflammation in mice and rats and has improved symptoms in humans with active Crohn's disease. Patients with Crohn's Disease between 18 and 75 years of age and who have active disease symptoms may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, electrocardiogram, blood and urine tests, chest x-ray and tuberculin skin test. They fill out diary cards for 7 days (measuring their symptoms on the Crohn's Disease Activity Index, or CDAI) and complete a 32-item Inflammatory Bowel Disease Questionnaire (IBDQ) that surveys how their disease affects their live and activities. Participants have a colonoscopy (an examination of the colon using a lighted tube) before starting the study medication. Colon tissue samples are biopsied during the procedure. Following the colonoscopy, patients are randomly assigned to receive either STA-5326 mesylate or placebo (sugar or dummy pill). They take four tablets a day and are seen in the clinic once a week (days 1, 8, 15, 22 and 29) for the following tests and procedures: Physical examination - Days 1, 8, 15, 22, 29 Blood tests - Days 1, 8, 15, 22, 29 Pharmacodynamic study (blood collected before the first dose of medicine and again after 1, 2, 4, 6 and 8 hours to measure levels of the drug in the blood) - Day 1 CDAI and IBDQ - Days 1, 15, 29 Review of medications and symptoms - Days 1, 8, 15, 22, 29 EKG - Days 8, 29 Pregnancy test for women of child-bearing potential - Days 15, 29 Urine test - Day 29 After patients complete the above treatment and tests, they undergo a second colonoscopy within 48 hours of their last dose of study medication and may be offered another 1-week supply of medication. Those for whom additional treatment is deemed potentially beneficial are offered another 4-week course of drug or placebo (continuing whichever they took the first 4 weeks). They come to the clinic for two visits 2 weeks apart (days 43 and 57) for a physical examination, blood tests, EKG, pregnancy test for women, CDAI, IBDQ and review of medications and symptoms. A urine sample is collected only on day 57. A third colonoscopy is done after all the tests are completed on day 57, within 48 hours after the last dose of study medication. Patients return to the clinic about 1 week after their final dose of study medication (day 36 for patients who complete only 1 month of treatment and day 64 for those who complete a second month of treatment) for a limited physical examination, blood tests, pregnancy test for women, CDAI and IBDQ, and a review of their medications and symptoms.
Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease
Crohn's DiseaseThe study is being undertaken to evaluate whether delayed-release medications, designed to begin to open in the lower intestinal tract, the main site of Crohn's Disease, are more effective than standard systemically delivered drugs to promote remission or response in CD patients. It is hypothesized that the delayed-release medications will go right to the injured tissue and heal the disease more quickly. The delayed-release test drugs are 6-mercaptopurine (at a dose of 40 mg daily) or calcitriol (at a dose of 5 mcg three times a week) versus Purinethol (6-MP at a dose of 1-2 mg/kg body weight daily). Calcitriol is a synthetically manufactured replica of a natural substance in the body that is derived from Vitamin D. There is much medical evidence that shows that lack of Vitamin D can be a possible risk factor in developing autoimmune disorders, including Crohn's Disease. Moreover, calcitriol has been shown in animal models to improve the symptoms of Crohn's Disease.