Active clinical trials for "Crohn Disease"

This study will examine the safety and effectiveness of an experimental drug called J695 for treating patients with Crohn's disease-a long-term recurring inflammation of the small and large intestine. This disease is currently treated with steroids, sulfasalazine (Azulfidine), 5-ASA drugs (Pentasa, Asacol), immune suppressants, antibiotics, and an antibody against TNF-alpha. Despite the number and variety of available therapies for Crohn's disease, many patients do not respond adequately to treatment or they develop severe side effects from the medicines. Therefore, new treatments must be developed. J695 is an antibody that is identical to a human antibody but chemically changed so that it can attach to and eliminate an inflammatory chemical made by the body called interleukin-12 (IL-12). Animal studies have shown that eliminating IL-12 with an antibody can prevent inflammation in the gut and can also heal inflammation that has already developed. Patients 18 years of age and older who have had Crohn's disease for at least 4 months may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, chest X-ray, blood and urine tests, stool analysis and possibly a review of medical records. They will complete a Crohn's Disease Activity Index Questionnaire for 7 days. Participants will be randomly assigned to one of two treatment groups, as follows: Group 1 Patients in this group will receive an injection of either J695 or placebo (a solution that does not contain any active medicine) under the skin on day 1 of the study, on day 29, and then weekly for a total of seven injections. After the last injection, patients will be followed for an additional 18 weeks. They will be monitored periodically throughout the study with physical examinations, disease activity index scores, and blood and urine tests. Group 2 Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and then weekly for a total of six injections. They will be followed for an additional 18 weeks. Patients will be monitored as described above for group 1. Participants may be asked to undergo additional tests as part of a sub-study in this protocol. These include colonoscopies to examine changes in inflammation in the gut and blood tests to analyze changes in the cells and body chemicals that affect the inflammation.

There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative colitis (UC).

The purpose of this study is to determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppressive therapy. In addition, the study will determine the effect of PEG lavage alone on fecal calprotectin and gut microbiota in patients who are undergoing a PEG lavage for clinical care.

To evaluate the effects of infusion of a Fish oil-based lipid emulsion on TNF-α production and other relevant immune functions. A soybean oil emulsion, rich in the omega-6 polyunsaturated fatty acid linoleic acid, will serve as control.

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 purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.

This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Half of the patients in this study will receive the CDED alone while the other half will receive the CDED and a liquid diet formula, for 24 weeks.

Objectives: To examine the effect of drug level-based personalized treatment of adalimumab in children with Crohn's disease. Design: A prospective, randomized, open label study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 17 years who are diagnosed with CD and are planned to receive adalimumab treatment. Main outcome measures: Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome measures: Corticosteroids free remission rates and on adalimumab at 48 and 72 weeks. The effect of routine adalimumab drug monitoring-based treatment on trough levels and anti-adalimumab antibodies during therapy.

The goal of the present study is to evaluate if addition of methotrexate can restore remission after loss of response to infliximab after dose escalation. another goal is to evaluate if low dose methotrexate can maintain remission achieved by regular dose methotrexate by 6 months.

The primary objectives of the study are: -To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）