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Colitis clinical trials

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NCT ID: NCT02246686 Terminated - Colitis, Ulcerative Clinical Trials

Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

Start date: November 2014
Phase: Phase 2
Study type: Interventional

The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.

NCT ID: NCT02217722 Terminated - Clinical trials for Ulcerative Colitis (UC)

Use of the Ulcerative Colitis Diet for Induction of Remission

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

The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of Remission. The investigators have postulated that we developed could be beneficial for patients with Ulcerative Colitis. To date, no study has explored this possibility.

NCT ID: NCT02144350 Terminated - Ulcerative Colitis Clinical Trials

Hyperbaric Oxygen for Ulcerative Colitis

Start date: August 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. The investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.

NCT ID: NCT02142725 Terminated - Ulcerative Colitis Clinical Trials

Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis

PROTECT-1
Start date: July 21, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.

NCT ID: NCT02118584 Terminated - Ulcerative Colitis Clinical Trials

Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

COTTONWOOD
Start date: September 15, 2014
Phase: Phase 3
Study type: Interventional

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.

NCT ID: NCT02092389 Terminated - Clinical trials for Moderate to Severe Ulcerative Colitis

Fecal Calprotectin Levels, QoL and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

AdaProQuo
Start date: July 2014
Phase: N/A
Study type: Observational

The objectives of this study are to explore the effect of adalimumab on the fecal Calprotectin level of Ulcerative Colitis (UC) patients and the correlation with their general well-being (QoL), work ability and disease activity.

NCT ID: NCT02058524 Terminated - Ulcerative Colitis Clinical Trials

A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis

Start date: June 2013
Phase: Phase 1
Study type: Interventional

The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.

NCT ID: NCT02000453 Terminated - Colitis, Ulcerative Clinical Trials

Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.

Start date: December 20, 2013
Phase: Phase 1
Study type: Interventional

This is an open label exploratory study to investigate the safety of 400 milligram (mg ) twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6 out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week 2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead electrocardiogram (ECG), physical examination, and adverse event reporting. These are standard measurements to evaluate safety.

NCT ID: NCT01959048 Terminated - Clinical trials for Clostridium Difficile

Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis

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

Clostridium difficile has become one of the leading causes of hospital acquired infections, and is associated with increased mortality. Patients with C. difficile associated disease (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result of earlier antibiotic usage. The current standard of care treatment for severe C. difficile, which consists of antibiotics, does not restore the microbiota. Restoration of the normal colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic microbial population to a more 'normal'state and lead to cure. A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic megacolon. The management in this context is based on limited data, and for some the only available option is sub-total colectomy. Although FMT is by no means a new therapeutic modality, there is limited information on its use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and mortality associated with treatment of patients with severe CDAD, and because the evidence supporting the current recommendations is weak and based upon the demonstration that FMT is an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD. Patients with severe CDAD can be divided into two operational groups; those that have diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through colonoscopy for all patients because current data suggest that the overall success rate of FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality), intra-colonic FMT administration is the preferred alternative.

NCT ID: NCT01953354 Terminated - Colitis, Ulcerative Clinical Trials

Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.