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Ulcerative Colitis clinical trials

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NCT ID: NCT02227602 Completed - Ulcerative Colitis Clinical Trials

Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease

Start date: January 2014
Phase: N/A
Study type: Interventional

Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy of mangoes has not previously been compared with respect to mild inflammatory bowel disease. In order to justify future pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step. Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would have a significant impact on public health.

NCT ID: NCT02227342 Completed - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis

Start date: July 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.

NCT ID: NCT02213835 Completed - Ulcerative Colitis Clinical Trials

Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis

SCD
Start date: June 2014
Phase: N/A
Study type: Interventional

The aim of this study is to determine the tolerability and potential efficacy of dietary therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with Crohn's disease (CD) and Ulcerative Colitis (UC). This is a single center, open labelled study designed to determine tolerability, preliminary safety and potential efficacy in pediatric patients with CD and UC. The study patients will be recruited from Seattle Children's GI clinic. the investigators will enroll 10 patients with mild to moderate CD (defined as PCDAI score of 10-29) or Ulcerative colitis (PUCAI 10-60) ages 8 to 21 years. Each patient will be in the study for approximately 12 weeks.

NCT ID: NCT02209987 Completed - Ulcerative Colitis Clinical Trials

Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults

Start date: August 2014
Phase: Phase 1
Study type: Interventional

This study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV administration.

NCT ID: NCT02200445 Completed - Ulcerative Colitis Clinical Trials

Low Dose IL-2 for Ulcerative Colitis

Start date: February 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.

NCT ID: NCT02197780 Completed - Ulcerative Colitis Clinical Trials

Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD

CACATU
Start date: September 2014
Phase: N/A
Study type: Observational [Patient Registry]

RATIONALE: A substantial proportion of children and teenagers with suspected inflammatory bowel disease (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical decision rule that included a calprotectin stool test to discern which patients require further investigations. The accuracy of this diagnostic strategy is 88.5% with a low risk of missing IBD cases. Although the number of negative endoscopies was reduced after introduction of this strategy, still 22% of the referred children and teenagers underwent an unnecessary invasive test. S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by activated neutrophils and this stool marker may be more IBD-specific than calprotectin. OBJECTIVE: To determine whether the specificity of S100A12 is superior to the specificity of calprotectin without sacrificing sensitivity HYPOTHESIS: Inclusion of the calgranulin C stool test will improve the specificity of the screening-strategy.

NCT ID: NCT02179372 Completed - Ulcerative Colitis Clinical Trials

Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Start date: June 2014
Phase: N/A
Study type: Interventional

The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.

NCT ID: NCT02171429 Completed - Ulcerative Colitis Clinical Trials

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

HIBISCUS II
Start date: November 14, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naIve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28948; NCT02163759) was independently conducted.

NCT ID: NCT02163759 Completed - Ulcerative Colitis Clinical Trials

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

HIBISCUS I
Start date: November 4, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.

NCT ID: NCT02161640 Completed - Ulcerative Colitis Clinical Trials

Vascular Dysfunction in Paediatric IBD

Start date: September 2014
Phase: N/A
Study type: Observational

Inflammatory Bowel Diseases (IBD) is a group of relapsing and remitting gut inflammatory conditions acquired due to genetic susceptibility and/or environmental triggers. The disease manifestations are being increasingly seen in young children and the life-long debilitation has a severe effect on quality of life. Limited evidence suggests, although rare, in some young IBD individuals vascular complications may ensue. This leads to increased risk of vascular problems such as thrombosis, arterial disease and stroke. In the present project we aim to study and highlight potential vascular changes in young Inflammatory Bowel Disease (IBD) patients and compare these changes with age and gender matched controls. Vasculature will be measured in multiple ways including blood analysis in the laboratory and non-invasive, physiological measures of arterial health (e.g. ultrasound arterial scan). Our overall goal is to identify biomarkers indicative of increased risk of vascular dysfunction as this will open new avenues for early therapeutic intervention.