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Colitis, Ulcerative clinical trials

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NCT ID: NCT01813500 Completed - Ulcerative Colitis Clinical Trials

Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients

Start date: October 2011
Phase: N/A
Study type: Observational

The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A and B and is increasing faster in IBD patients, than the general population. Clinically, CDI in patients with IBD leads to a range of clinical syndromes from symptomless carriage, to severe life threatening colitis, colectomy and death. This pilot study will look at the relationship between IBD and this variable host immune response. Clostridium difficile colonization (asymptomatic carrier state) is lower in the IBD population than in the general population. In the general population, high antitoxin titers have been linked with colonization and low antitoxin titers with recurrent disease. The investigators hypothesize that patients with IBD will have a lower Clostridium difficile colonization and will have lower antibody titers than the control group. Additionally those with lower titers will have an increased risk of developing CDI. In Aim 1 the investigators will determine Clostridium colonization in IBD subjects by stool study (including CD, UC and UC patients after IPAA) compared to non-IBD subjects (controls). In Aim 2 the investigators will compare antitoxin titers in these IBD subjects compared to controls. In Aim 3 the investigators will follow these subjects for 12 months and calculate the incidence of CDI in patients with IBD compared to controls and associations with anti-toxin titers.

NCT ID: NCT01810185 Withdrawn - Ulcerative Colitis Clinical Trials

Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The investigators will be looking at the efficacy of the use of once daily use of low dose naltrexone (4.5mg) in subjects with symptomatic inflammatory bowel disease.

NCT ID: NCT01805791 Terminated - Ulcerative Colitis Clinical Trials

A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

Start date: March 2013
Phase: Phase 3
Study type: Interventional

A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo.

NCT ID: NCT01804166 Completed - Clinical trials for Hepatosplenic T-Cell Lymphoma

A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

Start date: March 21, 2013
Phase: Phase 4
Study type: Interventional

This 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.

NCT ID: NCT01798953 Completed - Ulcerative Colitis Clinical Trials

Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

Start date: January 2010
Phase: N/A
Study type: Observational

Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this study was to determine the functional outcome after surgery, frequency of pouchitis, complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.

NCT ID: NCT01790061 Recruiting - Ulcerative Colitis Clinical Trials

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Start date: February 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

NCT ID: NCT01787786 Withdrawn - Ulcerative Colitis Clinical Trials

Improving Treatment of Inflammatory Bowel Diseases Through Better Understanding Infliximab Drug and Antibody Levels

OPTIMIZE
Start date: n/a
Phase: N/A
Study type: Observational

The purpose of this study is to develop a predictive model that will allow optimized dosing of infliximab for individual patients

NCT ID: NCT01783119 Recruiting - Ulcerative Colitis Clinical Trials

Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis

AVIUC
Start date: August 2012
Phase: Phase 0
Study type: Interventional

The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a beneficial effect in different disease, and have an anti-inflammatory effect in UC patients. Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a period of three months, in the degree of inflammation in patients with mild UC based on Mayo scale and quantification of IL-6 in the colonic mucosa.

NCT ID: NCT01772615 Completed - Ulcerative Colitis Clinical Trials

Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Start date: May 2011
Phase: Phase 4
Study type: Interventional

Purpose: The purpose of the study is to investigate if treatment with ciprofloxacin for one week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease activity among ulcerative colitis patients with disease flare-ups compared to placebo controls.

NCT ID: NCT01771809 Completed - Ulcerative Colitis Clinical Trials

Long-Term Safety Of PF-00547659 In Ulcerative Colitis

TURANDOT II
Start date: March 18, 2013
Phase: Phase 2
Study type: Interventional

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.