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Colitis, Ulcerative clinical trials

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NCT ID: NCT02445365 Completed - Clinical trials for Inflammatory Bowel Diseases

Remote Ischemic Conditioning in Patients With Ulcerative Colitis

Start date: May 2015
Phase: N/A
Study type: Interventional

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve treatment as well as diagnostic and prognostic tools. This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemic conditioning (RIC) in patients with moderate active ulcerative colitis (UC). The investigators hypothesize that RIC beyond the well known effect on reperfusion tissue damage has a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated brief and non-harmful suppression of blood circulation in a limb. The mechanism of action of RIC is likely to involve suppressed inflammation and cell death. Our study is a randomized clinical controlled study including 38 patients. Patients will receive RIC or sham for 10 consecutive days. The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopy findings, and various markers in the blood, faeces and the intestinal wall.

NCT ID: NCT02442960 Completed - Ulcerative Colitis Clinical Trials

Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis

SA100
Start date: December 2014
Phase: Phase 1
Study type: Interventional

This is a 12-week, open-label, dose-escalation Phase 1b study of a herbal treatment given orally to subjects with ulcerative colitis. Subjects will be sequentially enrolled to one of two cohorts in up to two clinical sites. Treatment will be given for 8 weeks and study duration will be 12 weeks.

NCT ID: NCT02442037 Recruiting - Ulcerative Colitis Clinical Trials

Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis

UCMSC-UC
Start date: May 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis,randomized, single blind, controlled prospective study.

NCT ID: NCT02439372 Completed - Ulcerative Colitis Clinical Trials

Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis

ACE-UC
Start date: April 2015
Phase:
Study type: Observational

Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. Theoretically, CMV-specific cell-mediate immune response will further categorize the patients into high or low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV colitis on ulcerative colitis flare.

NCT ID: NCT02438410 Completed - Clinical trials for Inflammatory Bowel Disease

Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis

Start date: May 2015
Phase:
Study type: Observational

To assess if infliximab drug levels in subjects with Ulcerative Colitis predict risk of colectomy rate. Additionally, the investigators will estimate an optimal day 4 infliximab level based on the study results.

NCT ID: NCT02435992 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Start date: June 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

NCT ID: NCT02435160 Not yet recruiting - Ulcerative Colitis Clinical Trials

The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis

Start date: May 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of our study is to investigate the efficacy and mechanism in fecal microbiota transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC) patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT) treatment,the safety and efficacy of FMT will be observed.

NCT ID: NCT02426372 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis

NCT ID: NCT02425865 Completed - ULCERATIVE COLITIS Clinical Trials

Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET

In-TARGET
Start date: December 2016
Phase: Phase 4
Study type: Interventional

PHASE: IV TYPE OF STUDY: With direct benefit DESCRIPTIVE: multicenter, open-label, uncontrolled trial INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2. OBJECTIVE: To determine the proportion of patients with Continuous Clinical Response (CCR) and endoscopic remission after one year of golumimab at week 54. STUDY DESIGN: Induction Phase : Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg Maintenance Phase I : Week 10-Week 54 Week 10-Week 54 • Patients with primary clinical response*: Standard regimen with golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg) - Patients without primary clinical response at week 10 or with flare between week 10-week 54*: Optimization to 100 mg Q4W (or combination therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already on azathioprine at golimumab initiation or patient with known intolerance to thiopurines) - Early escape at Week 18: Primary non-responders who are still not responding at week 18 to dose optimization at Weeks 10 and 14 will be considered treatment failures and will be followed up (call or visit) at week 54 for safety. - Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3 points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from baseline in the rectal bleeding sub score ≥1 Intermittent Phase II : Week 54-Week 108 • Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab and continuation of thiopurines or methotrexate if on combination therapy • Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to 50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy • Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)

NCT ID: NCT02423512 Completed - Ulcerative Colitis Clinical Trials

The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness

Start date: June 2015
Phase: N/A
Study type: Observational

Vedolizumab is a new medication being used for the treatment of Crohn's disease and Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7 lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous studies have shown that patients who have previous exposure to another type of medication for Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to vedolizumab as well as those who have never been exposed. This study will investigate biologic markers in the blood and tissue the help identify possible reasons for this difference.