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Colitis clinical trials

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NCT ID: NCT00304369 Completed - Clinical trials for Pseudomembranous Colitis

Response of Clostridium Difficile Infection to Metronidazole Therapy

Start date: June 2005
Phase: N/A
Study type: Observational

In this record review study, our objective is to determine the rates of cure, failure and relapse following treatment of C. difficile colitis with metronidazole.

NCT ID: NCT00304356 Completed - Clinical trials for Pseudomembranous Colitis

Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.

NCT ID: NCT00303381 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of Interferon-Beta-1a (Rebif®) for Treating Subjects With Acute Symptoms of Ulcerative Colitis

Start date: December 2001
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in subjects with active ulcerative colitis (UC).

NCT ID: NCT00299013 Completed - Ulcerative Colitis Clinical Trials

Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

Start date: March 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.

NCT ID: NCT00295282 Completed - Ulcerative Colitis Clinical Trials

A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis

Start date: January 2006
Phase: Phase 1
Study type: Interventional

This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg. Three to six patients will be enrolled at each dose level, starting at the lowest dose level, for a maximum of 24 patients to be enrolled into the study. The study is designed to establish the safety and tolerability of single doses of MDX-1100 administered in dose-escalating cohorts to patients with ulcerative colitis. Other study objectives include characterizing a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and determination of immunogenic response to MDX-1100.

NCT ID: NCT00274209 Completed - Ulcerative Colitis Clinical Trials

Chromoendoscopy for Ulcerative Colitis Surveillance

Start date: December 2005
Phase: N/A
Study type: Observational

Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.

NCT ID: NCT00272818 Completed - Colitis Clinical Trials

Study to Identify Non-Invasive Markers of Gastrointestinal Allergy

Start date: September 2004
Phase:
Study type: Observational

The incidence of gastrointestinal allergy is on the rise and can be manifest in a number of different clinical presentations. The goal of this study is to evaluate the measurement of CD23, a protein that can be identified stool, urine, and blood, as a non-invasive marker for use in the diagnosis and interval assessment of patients with known or suspected gastrointerstianl allergy. Eosinophilic esophagitis (EE) is a disorder typically found in school-age and adolescent children, and is more prevalent in male patients. Patients with EE typically present with symptoms of heartburn or difficulties swallowing. Blood and x-ray studies may be normal or display non-specific findings. The diagnosis of EE rests on a combination of clinical symptoms, and the results of endoscopic and histologic studies. There is currently no biochemical marker that can be used to monitor disease course in these patients. Cow milk protein intolerance (CMPI) is an allergic process affecting the distal gastrointestinal tract in infants. As such, it often presents as diarrhea without or without the presence of gross rectal bleeding in infants ranging in age from birth to 6 months of age. Children display symptoms of abdominal disress including emesis, cramping, colic, or feeding difficulties. The diagnosis is based on an appropriate clinical history and supporting physical exam (typically normal). Treatment involves removal of the offending dietary antigens which include cow or soy milk protein Eosinophilic crypt abscesses, or collections of eosinophils within the intestine can also be seen. CD23 is a protein that can be found on allergy-type white blood cells (eosinophils), as well as on the cells that line the gastrointestinal tract. Previous studies have reported increased levels of CD23 in infants with cow's milk allergy. CD23 is also elevated in infants and children with allergic disease. Levels of CD23 appears to fall in conjunction with therapy.

NCT ID: NCT00269438 Completed - Ulcerative Colitis Clinical Trials

New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis

Start date: December 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of therapy.

NCT ID: NCT00267306 Completed - Clinical trials for Severe Ulcerative Colitis

Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis

Start date: January 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy. What is visilizumab? Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. Visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis. Who can participate in this study? The target population for this study is adults with severe ulcerative colitis that has resisted intravenous (IV) steroids. This study is open to patients with the following characteristics: - 16-70 year olds - A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry - Active disease despite ongoing treatment with steroids How is this study conducted? Eligible participants will be administered visilizumab as one daily injection on two consecutive days. All medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. This includes all visits, examinations and laboratory work. How does one get more information? This study is currently enrolling patients at hospitals and clinics in North America and Europe. For more information on the study or how to participate in it, please call 1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.

NCT ID: NCT00261118 Completed - Ulcerative Colitis Clinical Trials

Rituximab in Active Ulcerative Colitis

Start date: April 2004
Phase: Phase 2/Phase 3
Study type: Interventional

There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease. Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes) from the circulation. These cells have the capacity to generate the auto-antibodies that typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis and has an excellent safety record. This is a small placebo-controlled trial to assess its efficacy and safety in patients with steroid-resistant active ulcerative colitis.