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Colitis, Ulcerative clinical trials

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NCT ID: NCT02749630 Completed - Ulcerative Colitis Clinical Trials

A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)

Start date: April 11, 2016
Phase: Phase 1
Study type: Interventional

This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with UC, and in participants with CD across multiple sites.

NCT ID: NCT02748590 Completed - Clinical trials for Active Ulcerative Colitis

Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)

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

Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.

NCT ID: NCT02745678 Completed - Colitis, Ulcerative Clinical Trials

Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Start date: January 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.

NCT ID: NCT02743806 Terminated - Crohn Disease Clinical Trials

Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

Start date: August 1, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.

NCT ID: NCT02738125 Completed - Clinical trials for Ulcerative Colitis (UC)

Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions

SOTHIS
Start date: April 29, 2016
Phase:
Study type: Observational

This study assesses the long?term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.

NCT ID: NCT02735941 Completed - Ulcerative Colitis Clinical Trials

Study on Cannabinoid Receptor Expression in Gastrointestinal Diseases

Start date: June 13, 2017
Phase:
Study type: Observational

The purpose of the study is to investigate phospholipid ligands and their receptors in inflammatory bowel diseases and colon cancer. Several new species of lipids have been recently discovered which are able to transmit information to cancer cells in the large intestine. The lipids and their responsive receptors build an axis that is thought to influence the development of inflammation and cancer.

NCT ID: NCT02734589 Terminated - Ulcerative Colitis Clinical Trials

Fecal Transplantation Using a Diet for Donor and Recipient in Refractory Colitis

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially sustained remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose that use of a donor and recipient diet designed for UC during fecal transplantation will be superior to diet alone of fecal transplantation alone and will improve patient outcomes.The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients+ 20 subjects for dietary controls with the UC diet alone.

NCT ID: NCT02729233 Withdrawn - Ulcerative Colitis Clinical Trials

Predicting Clinical Response to Golimumab With Mucosal Barrier Dysfunction

Start date: January 2017
Phase: N/A
Study type: Interventional

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). UC is an ongoing disease of the colon or large intestine. Studies have shown that leakiness of the gut plays a major role in the development of UC. Leakiness of the gut is a condition that is a result of damage to the intestinal lining, making it less able to protect its internal environment as well as to filter needed nutrients and other substances. Some bacteria, toxins, and waste not normally absorbed may get into the blood stream. Golimumab is an FDA approved medication used for the treatment of moderate to severe ulcerative colitis. The investigators have evidence to suggest that measuring the leakiness of the gut using a tool called a confocal laser endomicroscope may be able to predict how well a patient's body will respond to treatment of UC with golimumab. Confocal laser endomicroscopy (CLE) is an FDA approved technique that can look at the cells of a patient's gut during colonoscopy to assess the leakiness of gut. The objective of this study is to determine how the leakiness of the gut in patients with UC can predict response to golimumab therapy.

NCT ID: NCT02727959 Completed - Crohn Disease Clinical Trials

Inflammatory Bowel Disease in South Eastern Norway

IBSENIII
Start date: January 1, 2017
Phase:
Study type: Observational

The IBSEN III study will investigate the incidence of inflammatory bowel disease in South Eastern Norway and describe the clinical course of the disease. The investigators will map newly diagnosed and treatment naive IBD patients at various levels (epidemiological, clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and microbial) as a basis to improve targeted and individualized treatment and care. The investigators will include incident IBD patients at all local- and university hospitals in the South Eastern Health Region in 2016-2018 and follow-up prospectively for five years. The investigators will use standardized and validated registration methods allowing comparability with previous national and international IBD cohorts, link data to national health registries and collect blood, feces and biopsies for bio banking.

NCT ID: NCT02721823 Recruiting - Ulcerative Colitis Clinical Trials

Randomized Controlled Trial of Stress Reduction and Lifestyle Modification for Ulcerative Colitis

MBMCol
Start date: March 2016
Phase: N/A
Study type: Interventional

Patients with ulcerative colitis often suffer significant limitations to their quality of life, which are also conditioned by particular stress and psychosocial accompanying symptoms of the disease. A multimodal program for stress-reduction and lifestyle-modification has been shown to be effective in promoting the quality of life. The study will examine the promotion of the quality of life of patients with ulcerative colitis and the positive Influence on stress, psychological symptoms and physiological parameters. 92 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the disease-specific quality of life, the secondary outcomes are stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome.