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Colitis clinical trials

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NCT ID: NCT04338204 Recruiting - Ulcerative Colitis Clinical Trials

Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden

ODEN
Start date: September 18, 2020
Phase:
Study type: Observational

This is a prospective observational study using data from an existing, ongoing National Swedish registry (SWIBREG). This study is designed to assess the effectiveness and treatment adherence of tofacitinib on clinical disease activity parameters in patients with ulcerative colitis in Swedish clinical practice. The study will also assess treatment adherence of tofacitinib using the Swedish Prescribed Drug Register.

NCT ID: NCT04332328 Not yet recruiting - Clinical trials for Diet in Ulcerative Colitis Patients

Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt

Start date: April 1, 2020
Phase:
Study type: Observational

Diet is known to play role in the complex etiology of UC.Patient with UC tend to adapt unguided dietary habits without the guidance of a dietician or physician (Dejong,M.J 2019).so identification of nutritional gaps is needed to facilitate the development of evidence-based dietary guideline and subsequently give correct dietary advice to UC patients(Haskkey,N et al 2017).

NCT ID: NCT04329481 Recruiting - Ulcerative Colitis Clinical Trials

The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients

Start date: June 12, 2018
Phase: N/A
Study type: Interventional

Studies demonstrated that fungi have a complex, multifaceted role in the gastrointestinal tract and are active participants in directly influencing health and disease through fungal-bacterial, fungal-fungal and fungal-host interactions. Fungi have been linked with a number of gastrointestinal diseases including IBD, However, the exact role of fungal colonization in the pathophysiology of "IBD" (inflammatory bowel diseases) is not precisely defined. Aim to evaluate the impact of "Mycodigest" supplementation to IBD patients on: Clinical response and remission rates , Quality of life, Inflammatory markers, Fecal microbiome

NCT ID: NCT04314375 Recruiting - Ulcerative Colitis Clinical Trials

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Start date: September 29, 2023
Phase: Phase 4
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.

NCT ID: NCT04312113 Recruiting - Ulcerative Colitis Clinical Trials

Angiographic Delivery of AD-MSC for Ulcerative Colitis

Start date: November 16, 2020
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT04309058 Not yet recruiting - Ulcerative Colitis Clinical Trials

Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism

Start date: March 2020
Phase: Early Phase 1
Study type: Interventional

Aims:Prospectively observe the effects of Vitamin D drops supplementation on the chronic course of ulcerative colitis patients, analyze whether the effect of Vitamin D drops on UC patients is affected by factors such as disease site, disease activity, treatment, etc.Exploring the relationship between Fok I gene polymorphism and the efficacy of vitamin D supplementation. 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 100 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 Fok I gene polymorphism in all participants.One group is given Vitamin D drops 400IU per day orally, and the control group do not intervene. Participants' disease activity is assessed at baseline and related indicators are determined. The disease activity is re-evaluated in the 3rd, 6th, 9th, and 12th months, and the serum indexes are re-evaluated.Investigators use statistical methods to analyze whether Vitamin D drops supplementation treatment can increase the serum 25 (OH) D level of UC participants, improve the condition of UC participants,relationship with Fok I gene polymorphism,and analyze the effects of Vitamin D drops on participants with UC is affected by factors such as disease site, disease activity, and treatment.

NCT ID: NCT04305145 Recruiting - Melanoma Stage IV Clinical Trials

Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Start date: August 31, 2020
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the safety and effectiveness of infliximab compared to steroids for the treatment of immune checkpoint inhibitor-induced colitis (ICI colitis) in patients with stage III/IV skin cancer. The main questions this study aims to answer are: - How many patients treated with infliximab experience steroid-free disease resolution after 7 weeks? - How many patients treated with steroids experience steroid-free disease resolution after 7 weeks?

NCT ID: NCT04279821 Recruiting - Clinical trials for Diverticulosis, Colonic

Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

Start date: February 1, 2020
Phase:
Study type: Observational

Colonic diverticula are common in Western countries, affecting up to 60% of subjects over 70 years of age. In about 80% of patients, colonic diverticula remain asymptomatic (diverticulosis), while approximately 20% of patients may develop abdominal symptoms (symptomatic uncomplicated diverticular disease, SUDD) and, eventually, complications such as bouts of diverticulitis or bleeding. A small proportion of patients with colonic diverticulosis may develop segmental colitis associated with diverticulosis (SCAD). SCAD is separate clinical disease with specific macroscopic (erythema, friability and ulcerations) and microscopic features characterized by chronic, mucosal inflammation involving the inter-diverticular mucosa (usually sigmoid colon) sparing the proximal colon and rectum colon. The most common symptoms of SCAD are rectal bleeding, diarrhoea and abdominal pain. To achieve SCAD diagnosis a correct biopsies sampling is mandatory. It is necessary to take biopsies on the borders of the diverticula and in the apparently normal adjacent mucosa as well as biopsies in both the colon proximal to the diverticular area and the rectum in order to exclude chronic inflammatory bowel disease. The spectrum of histological lesions associated with SCAD is variable, including mild non-specific inflammation and inflammatory bowel disease (IBD)-like changes. Currently, data regarding prevalence of SCAD are scarce. It has been estimated that in patients with diverticulosis, SCAD prevalence ranged from 0.3-1.3%. The aim of the present study is to assess prospectively the prevalence of segmental colitis associated with colon diverticulosis (SCAD), in consecutive patients with colic diverticulosis, in a tertiary university centre.

NCT ID: NCT04277546 Terminated - Ulcerative Colitis Clinical Trials

Open-label Extension Study of Brazikumab in Ulcerative Colitis

Expedition
Start date: March 3, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety and efficacy data obtained in this study will be included in regulatory product submissions as appropriate.

NCT ID: NCT04276740 Not yet recruiting - Clinical trials for Ulcerative Colitis Flare

MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis

MARVEL
Start date: May 31, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, multi-centered, randomized, placebo-controlled trial with treatment phase over 24 weeks. Ulcerative Colitis (UC) is a condition that causes inflammation and ulceration of the inner lining of the rectum and colon (the large bowel). In UC, ulcers develop on the surface of the lining and these may bleed and produce mucus. Individuals with UC can become very unwell with disabling bloody diarrhoea, uncontrollable bowel habit and profound tiredness. In very severe cases, UC carry the risks of rupture of the inflamed bowel wall requiring an emergency operation to remove the colon. The MARVEL study investigates whether MitoQ is a beneficial drug treatment for UC. Earlier studies have shown that the inflamed UC gut lining releases 'danger signals' arising from the mitochondria. These 'danger signals' attract immune cells and make inflammation worse. Mitochondria are the 'batteries' or 'power stations' that reside within, and provide energy for living cells. In the gut lining of individuals with UC, the mitochondria are more prone to damage that increases the release of these danger signals. MitoQ protects the mitochondria and exerts an anti-inflammatory effect. The investigators hypothesise that MitoQ will improve UC and allow the bowels to heal properly following a disease flare. In the MARVEL study, individuals with an active flare of UC requiring standard oral Prednisolone will be given either MitoQ or placebo as a daily capsule for 24 weeks. The Investigators will carry out an assessment after 12 and 24 weeks to find out if MitoQ will result in higher rates of improvement in the participants' symptoms and gut lining inflammation. Furthermore, the investigators will investigate if their UC will be better controlled and that they are less likely to need further steroids or more potent forms of drugs. MitoQ has been shown to be safe in 2 large human clinical studies in Parkinson's disease and Hepatitis C, but the MARVEL study will be the first study in UC. At low doses, MitoQ is used as a nutritional supplement that has an anti-oxidant effect. Currently, many drug treatments in UC are very strong, expensive and aimed at suppressing the immune system. If the MARVEL study provides supportive data, MitoQ can be a safe and cost-effective new treatment that works at blocking the specific inflammatory signal found in the gut lining of individuals with UC.