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231 active trials for Ulcerative Colitis

Low Dose IL-2 for Ulcerative Colitis

The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.

Start: February 2015

Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples

This is a prospective cohort study enrolling ulcerative colitis patients who initiate tofacitinib therapy. Investigators will collect clinical data, blood and stool samples prior to initiation of tofacitinib and, at minimum, monthly after the start of therapy. They will collect tissue from colonoscopies prior to initiation of therapy and within 6 months on therapy. Clinical characteristics and response to treatment will then be associated with genotype, blood immune profiles, stool microbiota, and cellular and molecular profiles of the biopsies to generate a treatment response model. Using predictors identified in our model, we will then attempt to validate the model and findings with the OCTAVE (Pfizer), SPARC (CCF), and RISK (CCF) data.

Start: December 2018

Multi-center Acute Severe Ulcerative Colitis Cohort Study (MASCC)

Ulcerative colitis (UC) is a chronic, progressive immunologically mediated disease affecting nearly 1 million Americans. Up to one third of patients with UC will require hospitalization for severe disease (termed 'acute severe colitis (ASUC)'), often within the first year after diagnosis. Investigators will develop a large multi-center cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical and laboratory data.

Start: November 2018

Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer

This is a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer.

Start: October 2020

Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Start: December 2018

Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

This is an open-label, prospective, observational study with the primary objective to characterize the pharmacokinetics of infliximab in patients with Acute Severe Ulcerative Colitis.

Start: December 2018

TUDCA as a Therapy for Ulcerative Colitis (UC)

This is a Phase I open label study examining the efficacy and safety of TUDCA (tauroursodeoxycholic acid) in ulcerative colitis treatment.

Start: January 2019

National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life

National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

Start: October 2016

Angiographic Delivery of AD-MSC for Ulcerative Colitis

Researchers are trying to determine the safety and feasibility of using an adipose derived mesenchymal stem cell (MSC) to treat people with Ulcerative Colitis.

Start: November 2020

Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups

The risk of colorectal cancer (CRC) is increased in patients having ulcerative colitis (UC). Patients with long-standing extensive colitis, concomitant primary sclerosing cholangitis, or previous history of dysplasia carry an exceptionally high risk of CRC and require regular and short-interval surveillance colonoscopy. Recent guidelines recommend surveillance colonoscopy based on target biopsy rather than random biopsy applying chromoendoscopy (CE) or narrow band image (NBI) technique in UC at risk for CRC. However, the diagnostic yield of NBI-based surveillance and CE-based surveillance is not extensively investigated in the high-risk UC population. The investigators aimed to compare the dysplasia detection rate of NBI with that of CE in UC patients with a high risk of CRC by performing a multicenter, randomized controlled trial.

Start: December 2020

The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis

The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to determine if the MDP results in changes to the intestinal bacteria or immune system.

Start: April 2017

Circadian Misalignment in Inflammatory Bowel Disease

This study is to explore the role the sleep/wake cycle (Circadian Rhythm) has on Inflammatory Bowel Disease. Participants will be asked to attend two clinic visits 14 days apart. Participants will complete a packet of questionnaires regarding their health and sleep habits. Over the 14 days between visits participants will be asked to wear a wrist actigraphy device that will measure their sleep-wake activity along with filling in a sleep diary. During the visits, participants will have a physical exam on visit 1 and on visit 2 participants will be asked to give blood, stool, and urine samples. Additionally, participants may also give sigmoid tissue samples during an optional unprepped limited flexible sigmoidoscopy procedure.

Start: November 2016

Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)

This is a randomized, double-blind placebo controlled study to assess for safety, tolerability and nutritional impact of oral serum bovine immunoglobulin (SBI) on pediatric patients and young adults with inflammatory bowel disease (IBD) as assessed by an increase in serum albumin and other nutritional markers including vitamin D level, pre-albumin, transferrin and iron saturation; and improvement in weight and body mass index. SBI is an animal derived protein isolate from the serum of cows containing >50% IgG. It has been used for patients suffering from irritable bowel syndrome, human immunodeficiency virus enteropathy and antibiotic-associated diarrhea for symptomatic relief of diarrhea with good results and minimal side effects. However its role in IBD has not yet been investigated. The investigators hypothesize that the study product will have a positive nutritional impact along with symptom improvement for pediatric and young adult patients with IBD. The volunteers for our study will have established Crohn's disease or ulcerative colitis and will be treated with a daily powder (SBI or placebo) added to their breakfast food (egg, yogurt, or peanut butter are best) for total of 60 days followed by 30 day monitoring period after completion of treatment. The volunteers will be followed by clinic visits and labs on day 0, day 15, day 60 and day 90. There is the potential for the treatment to alter disease activity, a secondary outcome, as assessed by measurement of serum markers of inflammation (ESR, CRP), fecal calprotectin (validated marker of intestinal inflammation), and clinical indices like short pediatric Crohn's disease activity index (shPDCAI) or pediatric ulcerative colitis activity index (PUCAI) for children and Harvey Bradshaw Index or SCCAI for adults. Stool samples will be collected on day 0 and day 60 for 16S RNA sequencing to assess for changes in microbiota of the participants while on the study product/placebo. We plan to enroll 43 patients in the study to allow for data analysis of atleast 30 patients. The study will take place over 1 year and will be conducted at University of Texas-Children's Memorial Hermann Hospital, where we follow > 125 children with inflammatory bowel disease.

Start: September 2020

Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases

TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

Start: January 2014

Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis

This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.

Start: January 2021

Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis

This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.

Start: October 2020

Russian Extremely Severe Ulcerative Colitis Study

The purpose of this study is prove the need to selection of a extremely severe ulcerative colitis, to identify predictors of colectomy, which will reduce the optimal time for surgery.

Start: June 2019

Infliximab Accelerated Induction in Moderate to Severe Pediatric UC

Objectives: To examine the effect of accelerated infliximab induction in children with moderate to severe UC. Design: A multi-center, prospective, randomized, open label study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 17 years (Overall, 84 patients) with moderate to severe UC who are corticosteroid dependent/resistant thus planned to receive infliximab induction. Intervention: Group 1 (intervention) will receive an accelerated induction at 0,1,3 weeks (5 mg/kg) and then at week 7,11,15. Group 2 (standard) will receive a per protocol induction at 0,2,6 weeks (5 mg/kg) and then at week 14. Drug levels will be obtained prior to each infusion in each group (up to week 20). Further maintenance will be planned according to drug levels at weeks 15 and 14, respectively. Follow-up will continue without further interventions till 52 weeks following induction. Main outcome measure: Clinical remission, on infliximab at week 20. Secondary outcome measures: 1. Colectomy free rates at week 20 and 52. 2. Clinical remission on infliximab at week 52. 3. Drug levels and anti-drug antibodies prior to last study infusion. 4. Anthropometric and laboratory measures including calprotectin at the end of induction, week 20 and week 52 5. Changes in fecal microbiome, virome and bile acids content. Sample size: In order to demonstrate 30% difference in clinical remission rate between groups is significant, we will need to study 36 children in each group to be able to reject the null hypothesis that the failure rates between the groups are equal with probability (power) of 80% and a type I error probability of 0.05.

Start: April 2018

Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient Reported Assessment

Inflammatory bowel disease (IBD) is a chronic relapsing immune mediated inflammatory disease (IMID) of the gastrointestinal tract. Like all IMIDs (e.g. rheumatoid arthritis, psoriasis) a complex interaction between a genetically altered immune response, the gut microbiota and environmental factors is causing the disease. Systemic suppression of the immune response with corticosteroids, immunomodulatory, biologicals and combination therapies increases the risk of opportunistic infections in IBD patients. Data on mild and moderate infections in medically treated IBD patients is scarce, mainly since infections treated by the general practitioner or in an outpatient setting are not systematically registered in real life. To help gastroenterologists with clinical decision making, real world data with long term follow-up concerning the risk for infectious complications, is warranted. Several observations underline the importance of real world data on mild and moderate infections in medically treated IBD patients. Mild and moderate infections mostly have a benign course, but they take longer to clear and have a large impact on (work)disability and quality of life in IBD patients. Recurrent infections influences peoples willingness to use a drug and negatively effects adherence. Furthermore, recurring mild and moderate infections might prognosticate serious infections, and systematic assessment of all infections could be used to timely adjust treatment regimens and prevent serious infections. The investigators of this study previously developed a questionnaire on self-reported infections according to the FDA guideline for patient-reported outcome measures (PROM) by interviewing 36 patients with IBD and through input of expert meetings with gastroenterologists, IBD specialists, rheumatologists, immunologists and IBD-nurses. This questionnaire has already been implemented in myIBDcoach, a validated telemedicine system implemented in routine care for over 4000 patients with IBD in the Netherlands. Assesment of reliability and validity are the last steps in validation of this remote monitoring tool. In the current study the investigators aim to: Assess the reliability, construct validity and criterion validity of a remote monitoring tool (questionnaire) for infections as last step in the validation Assess the relative risk of all infections (mild, moderate and severe) in a real-life population for IBD patients on different maintenance treatments Identify the predictors and risk factors of mild and moderate infections. Assess the relation between patient reported infections and the risk for serious infectious complications

Start: June 2020

Exploring the Effects of Caltrate Supplement on the Chronic Course of Ulcerative Colitis Patients With Vitamin D Deficiency

Aims:Prospectively observe the effects of Caltrate supplementation on the chronic course of ulcerative colitis patients, analyze whether the effect of Caltrate on UC patients is affected by factors such as disease site, disease activity, treatment, etc.Provide a certain theoretical basis for "precision treatment" for UC patients in the future. Design?It is a prospective cohort study. Investigators include a total of 60 participants with UC according to the inclusion and exclusion criteria, and divide them into two groups to assess their initial disease activity and detect related indicators. At the same time?Investigators detect the Vitamin D Gene gene polymorphisms in all participants.One group is given Caltrate 0.6g per day orally, and the control group do not intervene. After 12 months, re-evaluate the disease activity and retest the relevant indicators, and use statistical methods to analyze whether Caltrate supplementation treatment can increase the serum 25 (OH) D level of UC participants, improve the condition of UC participants,relationship with Vitamin D Gene Polymorphism?and analyze the effects of Caltrate on participants with UC is affected by factors such as disease site, disease activity, and treatment.

Start: October 2020