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Colitis clinical trials

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NCT ID: NCT02683733 Recruiting - Ulcerative Colitis Clinical Trials

Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis

Start date: February 2016
Phase: Phase 3
Study type: Interventional

Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of treatment options are directed at attempting to control the chronic inflammation and prolonging remission of clinical symptoms. Several studies have proven that curcumin has well-established anti-inflammatory properties. However, curcumin has poor bioavailability and prior studies have needed to use high concentrations in order to study the efficacy of the product. The investigators propose that a bio-enhanced preparation of curcumin will require a lower dosage to reach and affect its target tissue and will subsequently produce less adverse side effects.

NCT ID: NCT02676817 Recruiting - Colitis, Ulcerative Clinical Trials

Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis

ENHANCE
Start date: April 2015
Phase: N/A
Study type: Observational

The aim of the study is to construct and validate an endomicroscopic score correlated with microscopic inflammation activity in patients with UC. Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which offers the possibility to perform in vivo mucosal microscopic analysis in real time during endoscopy. Primary Objectives : Development and validation of a UC endomicroscopic score, after correlation between pCLE data and histological data using the Geboes' score as a gold standard during ulcerative colitis. Secondary Objectives: - Identify predictive factors for the response to adalimumab. - Identify predictive factors for recurrence in patients with UC in remission (Mayo score 0 or 1). - Safety of the pCLE procedure

NCT ID: NCT02674308 Completed - Clinical trials for Ulcerative Colitis and Crohn's Disease

Entyvio (Vedolizumab) Long Term Safety Study

Entyvio PASS
Start date: March 24, 2015
Phase:
Study type: Observational

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

NCT ID: NCT02665845 Completed - Ulcerative Colitis Clinical Trials

Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).

COMBOMESA
Start date: June 13, 2016
Phase: Phase 3
Study type: Interventional

The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation. The aim of this study is to compare the efficacy of steroids alone vs. combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

NCT ID: NCT02647866 Completed - Ulcerative Colitis Clinical Trials

Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.

NCT ID: NCT02646657 Completed - Colitis, Ulcerative Clinical Trials

An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis

LOVE-UC
Start date: July 2015
Phase: Phase 4
Study type: Interventional

This multi-centre open label study will involve a minimum of 120 patients in 2 cohorts: 60 patients with 'early UC' defined as disease duration < 4 years and no other treatments than aminosalicylates and/or corticosteroids and 60 patients with 'late UC' defined as active disease despite treatment with immunosuppressives (IS) and/or anti-TNF. Patients wih intolerance to IS AND anti-TNF will also be allowed in the latter group. Participants will be treated with 12 months of open label vedolizumab and undergo monitoring of endoscopic, histological and clinical disease parameters. No randomization or blinding will be performed but the study management will make sure recruitment in either study group is comparable for number and profile of patients (extent of disease and on/off corticosteroids).

NCT ID: NCT02640391 Completed - Ulcerative Colitis Clinical Trials

Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis

PINQLE
Start date: January 2016
Phase:
Study type: Observational

The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing in patients with quiescent ulcerative colitis (UC).

NCT ID: NCT02632175 Active, not recruiting - Ulcerative Colitis Clinical Trials

Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

Start date: November 26, 2015
Phase: Phase 3
Study type: Interventional

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

NCT ID: NCT02629211 Recruiting - Crohn Disease Clinical Trials

Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD

Start date: June 2016
Phase: N/A
Study type: Interventional

To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD.

NCT ID: NCT02622139 Completed - Ulcerative Colitis Clinical Trials

Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD)

MSOT_IBD
Start date: November 2015
Phase: N/A
Study type: Interventional

Monocentric, prospective interventional study to assess the degree of disease activity with a multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's disease or ulcerative colitis.