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231 active trials for Ulcerative Colitis

Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis

A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). All enrolled subjects will provide serological, stool and mucosal specimen at each clinic visit to help further define the alterations in microbial profiles and immune cell function in response to psyllium fiber after FMT treatment.

Start: January 2020

SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis

Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations with. In this study, the investigators hope to find out if dietary therapy by either the Specific Carbohydrate Diet (SCD) or the Mediterranean diet will help improve ulcerative colitis symptoms for patients with mild to moderately active disease. In addition, the investigators will compare disease activity and changes in the intestinal bacterial composition in the colon that occur with the Mediterranean or the SCD diet in active ulcerative colitis. This study is proposed as a single-site randomized trial consisting of 10 study visits to Massachusetts General Hospital (MGH) over 12 weeks. Participants in this study will be randomly assigned to the SCD or Mediterranean diet. The investigators ask that participants exclusively consume their assigned diet for 6 weeks, with all meals and snacks prepared by the metabolic kitchen within MGH. Participants will need to pick up food from MGH every 5-7 days, and will meet with a study dietitian before they begin and weekly during the diet therapy. There will be a screening visit to determine eligibility for the study, as well as study visits at weeks 0, 1, 2, 4, 6, and a 10 week follow-up at MGH, in which participants will fill out questionnaires. Participants will need to provide stool samples at screening, week 6, and week 10. In addition, blood will be drawn at week 0 and week 6, and if participants are getting a clinically-indicated colonoscopy at the time of screening, up to eight research biopsies may be collected during the procedure.

Start: September 2020

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

Start: April 2021

Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)

The main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population. The secondary objectives are: to assess the level of education and compare it to that of the general population to assess occupational insertion and the educational level according to: The disease (Crohn's disease, ulcerative colitis or unclassified colitis) sex Age at diagnosis (<or ? 10 years) The occurence of surgery, the location of the disease, the treatments undertaken Quality of life Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level To describe the quality of life of patients in relation to disease activity and health states (QALY calculation) To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)

Start: November 2019

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).

Start: February 2017

Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis

This study conducted a systematic clinical observation of the clinical efficacy of UCB-MNCs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy.

Start: June 2021

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Start: September 2019

Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.

Start: May 2021

Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2) Evaluation of the microbiota modulation potential of statins in Bact2- enterotyped, healthy volunteers and ulcerative colitis patients. Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis patients. Evaluation of reduced inflammatory parameters of participants involved in trial

Start: October 2020

Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

Start: October 2020

Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)

The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.

Start: October 2020

Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with mild to moderate UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.

Start: August 2019

Global IBD Visualization of Epidemiology Studies (GIVES) in the 21st Century

Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) of unknown etiology. The pathophysiology of IBD relates to the mucosal immune response to antigenic stimulation from the gut microbiota secondary to environmental influence, on a background of genetic susceptibility. IBD represents an important public health problem because it affects mostly young people at an age when they are most active in their private and professional life, and a management challenge because of its unpredictable relapsing nature. During the last few decades the incidence of IBD has changed in many ways. Incidence rates of traditionally high incidence areas such as the United States and Europe is remaining relatively stable or even decreasing, while the diseases have become more prevalent in previously low incidence areas, including Asia. Our latest systematic review has demonstrated that the highest reported prevalence of IBD was still in Europe and North America, however, the incidence of IBD has been rising in newly industrialized countries since 1990.

Start: June 2021

Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis

The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic score (MCS) in adults with moderately to severely active ulcerative colitis (UC).

Start: December 2019

Fermented Food-Supplemented Diet in Ulcerative Colitis

The purpose of this study is to see how a diet that supplements fermented foods effects inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC). There is a paucity of research and an enormous need for better understanding of diet and intestinal inflammation. Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.

Start: September 2020

The Influence of a Fasting Mimicking Diet on Ulcerative Colitis

The purpose of this study is to see how a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis (UC). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and UC are very limited. Fasting mimicking diets (FMD) have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after three cycles of a five-day period of the fasting mimicking diet, and may provide rationale for its use to treat UC.

Start: December 2020

The Role of Secondary Bile Acids in Intestinal Inflammation

The cause of Inflammatory bowel disease (IBD) is unknown, but intestinal bacteria-involved in the production of molecules that impact health-are widely accepted to play a key role. A significant proportion of IBD patients with pouches (surgically created rectums after the diseased colon is removed) continue to have inflammation similar to their previous disease. Only a few microbes are known to have the capability to modify primary bile acids (PBAs) made by the liver to secondary bile acids (SBAs). SBAs are some of the most common metabolites in the colon and play key roles in several diseases. In this study the investigators will investigate if ursodeoxycholic acid (UDCA) may reduce inflammatory markers and improve quality of life (as assessed by validate survey) in those subjects with active antibiotic refractory or antibiotic dependent pouchitis.

Start: August 2019

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis

Start: September 2020

Non Invasive Characterization of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Monocentric, prospective observational study to assess bowel inflammation in children with chronic inflammatory bowel disease (IBD) using multispectral optoacoustic tomography (MSOT).

Start: March 2021

A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab. At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment. Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.

Start: August 2021