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Colitis clinical trials

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NCT ID: NCT00279422 Terminated - Ulcerative Colitis Clinical Trials

A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Start date: February 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.

NCT ID: NCT00268164 Terminated - Ulcerative Colitis Clinical Trials

Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

Start date: June 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the lactic acid bacteria " Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12)" is effective as maintenance treatment in ulcerative colitis.

NCT ID: NCT00254618 Terminated - Ulcerative Colitis Clinical Trials

A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.

Start date: October 2005
Phase: Phase 1
Study type: Interventional

The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days to children and adolescents with active ulcerative colitis.

NCT ID: NCT00217022 Terminated - Diarrhea Clinical Trials

Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Start date: June 2003
Phase: Phase 2/Phase 3
Study type: Interventional

Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis.

NCT ID: NCT00209287 Terminated - Ulcerative Colitis Clinical Trials

Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis

Start date: June 2005
Phase: Phase 4
Study type: Interventional

Male or female, 18 years of age or older. Ulcerative Colitis described according usual criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-aminosalicylic acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at the inclusion. Signed informed consent form.

NCT ID: NCT00184171 Terminated - Colitis Clinical Trials

Treatment of Microscopic Colitis

Start date: November 2001
Phase: N/A
Study type: Interventional

The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis

NCT ID: NCT00152841 Terminated - Ulcerative Colitis Clinical Trials

Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis

Start date: June 2002
Phase: Phase 2
Study type: Interventional

Hypothesis:In patients with ulcerative colitis and Crohn's disease diagnosed with mild or moderate anaemia: 1. iron supplementation will increase disease activity and oxidative stress 2. the addition of antioxidant vitamin will reduce this detrimental effect

NCT ID: NCT00061282 Terminated - Ulcerative Colitis Clinical Trials

Clotrimazole Enemas for Pouchitis in Children and Adults

CAPTURE
Start date: September 30, 2002
Phase: Phase 1/Phase 2
Study type: Interventional

Colectomy with creation of an ileal pouch (IPAA) is now the treatment of choice for patients with ulcerative colitis that is resistant to existing medical therapies. The development of inflammation in these ileal reservoirs, a clinical entity referred to as pouchitis, is the most common long-term complication of this procedure and can affect 50-60% of adults and children. We have previously demonstrated that clotrimazole (delivered as a rectal suppository) is generally safe, effective, and displays poor systemic absorption when used in pediatric and adults with active pouchitis. We saw clinical benefit in patients with pouch disease that had previously failed to respond to standard antibiotic, steroid, or immunosuppressive therapies. The clinical trial outlined here will define the effectiveness and safety of topical clotrimazole therapy (delivered as a rectal enema) in pediatric (aged greater than two years) and adult patients with pouchitis. Subjects in this study will be randomly assigned to receive either placebo (no active drug, 4 subjects) or one of two clotrimazole therapy groups: 2500 mg/day (8 subjects) or 4000mg/day (8 subjects). No washout period is required, and subjects will be allowed to continue their existing anti-inflammatory medications during their participation in the study. Clotrimazole will be delivered nightly in the form of an enema. Subjects will undergo flexible sigmoidoscopy (pouchoscopy) prior to and again after completing one month of study therapy, and pouch disease activity will be graded at after each procedure using the Pouchitis Disease Activity Index (PDAI). Clinical improvement will be defined as a drop in PDAI score. If the drop in PDAI scores between placebo and either active clotrimazole treatment group is not significant, and no subject experiences what are determined to be study-related adverse effects, a second cohort of subjects will be recruited and studied after receiving one month of either placebo (4 subjects), 6000 mg/day clotrimazole (8 subjects), or 7500mg/day clotrimazole (8 subjects). Subjects will be assessed for adverse effects at the midpoint of the study. Clotrimazole blood levels will be measured during the first and last day of study participation. In addition, adults will complete a health related quality of life assessment at baseline and after completing study drug therapy. All subjects will be eligible for one month of open-label study drug therapy after completing one month of study drug therapy.

NCT ID: NCT00038922 Terminated - Ulcerative Colitis Clinical Trials

Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

Start date: n/a
Phase: Phase 1
Study type: Interventional

To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis. To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.