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Colitis, Ulcerative clinical trials

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NCT ID: NCT02818543 Completed - Ulcerative Colitis Clinical Trials

Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis

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

The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.

NCT ID: NCT02801240 Completed - Crohn's Disease Clinical Trials

Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

Individuals with IBD are at risk for nutrient deficiencies. This prospective, non-randomized, open-label study will assess the effect of a nutrition support product on nutritional status in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's disease will be enrolled in the study and asked to take the product for 12 weeks. The primary measures of the study are several blood markers of nutritional status.

NCT ID: NCT02799615 Completed - Colitis, Ulcerative Clinical Trials

Anti-TNF Therapy for Refractory Colitis in Hospitalized Children

ARCH
Start date: May 2016
Phase:
Study type: Observational

This multicenter study is being conducted to determine whether infliximab exposure after an initial infusion is predictive of early clinical response in hospitalized pediatric patients with severe steroid-refractory UC or IBD-U. This pilot and feasibility study will establish the infrastructure, demonstrate feasibility, and collect preliminary data to support the full study.

NCT ID: NCT02778464 Completed - Pregnancy Clinical Trials

Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease

PREGCAL
Start date: November 8, 2016
Phase:
Study type: Observational

When women with rheumatoid arthritis become pregnant 75% of them will go into remission, despite stopping medication. This phenomenon is not well understood and is not seen in other inflammatory conditions. Once they give birth they often relapse. Bacteria in the stool and inside the gut have the ability to effect the immune system and some beneficial bacteria are known to down regulate inflammatory components of the immune system. Gut bacteria are also known to alter significantly during pregnancy and in other inflammatory conditions there are low levels of beneficial bacteria associated with diseases like ulcerative colitis. There is significant crossover between rheumatoid arthritis and inflammatory bowel disease with similar arthritic symptoms and mechanisms of inflammation. There is very limited investigation of gut bacteria and rheumatoid arthritis, but some animal work has shown that treatment with probiotics and prebiotics can improve the condition. The aim of this study is to examine the bacteria in the stool of women who are pregnant with rheumatoid arthritis and identify any significant bacteria changes that might be used to direct future research.

NCT ID: NCT02770040 Completed - Ulcerative Colitis Clinical Trials

Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

PREDICT UC
Start date: July 18, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled trial.

NCT ID: NCT02762500 Completed - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis

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

The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1 at screening.

NCT ID: NCT02750800 Completed - Clinical trials for Rheumatoid Arthritis

Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)

VALUE
Start date: April 7, 2016
Phase:
Study type: Observational

The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) in the routine clinical setting in Hungary.

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.