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Ulcerative Colitis clinical trials

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NCT ID: NCT03301311 Not yet recruiting - Ulcerative Colitis Clinical Trials

Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease

PRODUCE
Start date: November 2017
Phase: N/A
Study type: Interventional

A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a three-year study. The study staff will recruit 120 patients (goal sample size of 100, accounting for attrition) across up to 12 sites in patients aged 7-17 with mild to moderate disease activity.

NCT ID: NCT03298022 Not yet recruiting - Ulcerative Colitis Clinical Trials

Efficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis

Start date: March 2018
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of Neihulizumab (AbGn-168H) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.

NCT ID: NCT03290781 Not yet recruiting - Ulcerative Colitis Clinical Trials

Study of the Effect of SHP647 as Maintenance Treatment in Participants With Moderate to Severe Ulcerative Colitis Who Achieved Clinical Response in Induction Studies

FIGARO UC 303
Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in participants with moderate to severe ulcerative colitis (UC) who achieved clinical response in induction studies. This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study.

NCT ID: NCT03283085 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis (AIDA)

Start date: January 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC).

NCT ID: NCT03282903 Recruiting - Ulcerative Colitis Clinical Trials

The PRognostic Effect of Environmental Factors in Crohn's and Colitis

PREdiCCt
Start date: November 1, 2016
Phase: N/A
Study type: Observational

The PREdiCCt Study: This is a major study that is now being launched. This is the first study of its kind and is specifically directed toward understanding how environmental factors and the gut microorganisms influence IBD flare and recovery. For the PREdiCCt study, the investigators hope to recruit 1500 people in remission from Crohn's disease or ulcerative colitis (illness under control) from 28 inflammatory bowel disease clinics across the UK. The investigators hope to conduct the study in the following stages;- 1. Patients with Crohn's disease, ulcerative colitis or inflammatory bowel disease unclassified (IBDU) in clinical remission (under control) will be approached in gastroenterology clinics across the country and invited to take part in the PREdiCCt study. Alternatively they will express their interest in the study after seeing PREdiCCt promotional leaflets/posters/videos/social media. 2. Participants will attend a clinic visit for routine tests and also to complete several questionnaires with a research nurse. 3. At home over the next week participants will complete detailed questionnaires assessing their environment and diet. Participants will also collect a stool and saliva sample and send this to our laboratories (the investigators have developed easy ways of doing this reliably by post). The stool sample is to analyse the microorganisms in the participant's gut and the saliva is used to analyse their DNA. 4. Investigators will then follow patients' progress over 24 months. They will be asked to complete a short questionnaire every month with a longer questionnaire after 12 months and culminating in a final questionnaire 24 months after their initial clinic visit. 5. If a participant experiences a flare, investigators will collect an additional stool sample; but most importantly investigators will look to see how the environmental and microorganism factors recorded at the beginning differ for those that flare up versus those that don't. What investigators hope to achieve;- 1. Finding out the environmental and dietary factors for patients to avoid because they trigger flare. 2. Finding out behaviours for patients to adopt because they bring about remission. 3. Finding out what the microorganisms that predict flare look like. 4. Gaining information which helps future studies aimed at finding better diets for IBD sufferers. 5. Developing ways of gathering information online from IBD patients about their well-being that doctors can routinely use. The investigators have assembled expert doctors, epidemiologists, microbiologists, nutrition scientists, and bioinformaticians. These experts will use the systems the investigators have put in place to make sure PREdiCCt succeeds. It will yield a lot of new information to help sufferers right away; but the information will also help to kick start many important future studies that will bring us ever closer to a cure for Crohn's disease and ulcerative colitis.

NCT ID: NCT03281304 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

Start date: November 17, 2017
Phase: Phase 3
Study type: Interventional

This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.

NCT ID: NCT03273465 Recruiting - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation in Ulcerative Colitis

Start date: March 27, 2017
Phase: Phase 2
Study type: Interventional

Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis. This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed adult patients with mild-moderate UC. The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation,in newly diagnosed adult patients with mild-moderate UC. All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.

NCT ID: NCT03269695 Not yet recruiting - Ulcerative Colitis Clinical Trials

Efficacy, Safety And Tolerability Of PF-06687234 As Add-On Therapy To Infliximab In Active UC Subjects Not In Remission

Start date: October 6, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.

NCT ID: NCT03268213 Recruiting - Ulcerative Colitis Clinical Trials

Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis

FMT
Start date: November 2013
Phase: Early Phase 1
Study type: Interventional

The rationale for fecal microbiota transplantation in patients with refractory Clostridium difficile and/or Ulcerative Colitis or indeterminate colitis is its ability to reconstitute the normal microbial homeostasis leading to resolution or improvement of symptoms caused by the bacteria or underlying inflammatory bowel disease. This is becoming an especially important treatment modality as antimicrobial therapy for Clostridium difficile is becoming less efficacious due to resistant strains such as the hypervirulent NAP1/ribotype 027 strain. Currently long-term follow-up data on patients who have undergone FMT is lacking. There are only scattered reports documenting the alteration of the enteric microbial composition and function status post transplantation. This study will significantly increase understanding of the short and long term safety, efficacy, and tolerability of FMT. It will also enable researchers to assess the change in the fecal microbiome after transplantation. Answers to these questions may lead to identification of key bacterial taxa to target future therapy.

NCT ID: NCT03266484 Not yet recruiting - Ulcerative Colitis Clinical Trials

Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease

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

The study is proposed as a single-site randomized double-blind placebo-controlled trial requiring 4 study visits, where two of the visits are combined with their appointment for routine clinical care. The study population will consist of patients with quiescent CD and UC and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible patients will be contacted at the time of their routinely scheduled office visit and consented for the study. Self-report and review of medical records will be used to obtain detailed information regarding their disease on an intake questionnaire completed by a research study coordinator. The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic supplement compared to placebo. We propose to examine the effect of a specific probiotic supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue symptoms in patients with quiescent IBD. Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline visit. The patient will receive either the probiotic supplement or placebo for 4 weeks. The first follow up visit will be at week 4 to check for adverse events on study treatment, to check accountability of probiotics/placebo, and to complete the set of questionnaires. Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment. At week 8, subjects will receive a phone call from a study research coordinator to check in with probiotics/placebo intake for treatment compliance and accountability records, and to complete the set of questionnaires ascertaining subjective symptoms. Last study visit will be at week 12 which is often combined with a regular office appointment. Subject will provide serum blood and stool sample, as well as complete the set of questionnaires.