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Colitis, Ulcerative clinical trials

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NCT ID: NCT04031482 Not yet recruiting - Ulcerative Colitis Clinical Trials

TARGET Registry A Project of the German Network for Intestinal Diseases in Cooperation With Other Corporate Partners

TARGET
Start date: October 2019
Phase:
Study type: Observational [Patient Registry]

By capturing possible or known risk factors, it will be possible to recognize connections between these risk factors and the disease, thus obtaining valuable insights into the cause of the disease. This in turn facilitates an improved evaluation of the treatment situation as well as influencing future framework conditions for preventive measures and planning treatments. Disease registries are thus crucial for the planning and structuring of health policies. The present registry protocol serves as a basis for the proper implementation of a registry for patients with chronic inflammatory bowel diseases. It describes the study rationale, objectives, design, participant groups, procedures and evaluation methods. Furthermore, it defines the responsibilities of each person involved in maintaining the registry and also forms the basis for decisions regarding evaluation by the Ethics Committee.

NCT ID: NCT04030676 Recruiting - Clinical trials for Cytomegalovirus Infections

QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis

RECOHFERRON
Start date: July 17, 2019
Phase: N/A
Study type: Interventional

CytoMegaloVirus (CMV) infection impairs evolution of Ulcerative Colitis (UC) leading to more severe and resistant to immunosuppressive therapies flare-up. CytoMegaloVirus (CMV) reactivation is assessed by the quantification of the CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load by real-time PCR (qPCR) in colonic biopsies; this assay is invasive and costly. The QuantiFERON-CytoMegaloVirus (QF-CMV) assay measures the immune response against CytoMegaloVirus (CMV) in a blood specimen.

NCT ID: NCT04029649 Not yet recruiting - Ulcerative Colitis Clinical Trials

Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis

Start date: August 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to determine the efficacy and safety of Beta-1,3/1,6-D-Glucan from mycelium extract of Ganoderma lucidum on ulcerative colitis

NCT ID: NCT04023396 Active, not recruiting - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

Start date: January 13, 2020
Phase: Phase 2
Study type: Interventional

A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

NCT ID: NCT04011943 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation for Health Improvement (TFM3)

TFM3
Start date: May 21, 2018
Phase: N/A
Study type: Interventional

Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.

NCT ID: NCT04006977 Not yet recruiting - Ulcerative Colitis Clinical Trials

Multistrain Probiotics Reduces UC Depression and Anxiety Scores

Start date: October 2019
Phase: N/A
Study type: Interventional

This pilot study aims to evaluate the effect of a 16-week duration of multistrain probiotic product (De Simone Fomulation (DSF), previously known as VSL#3 and now available as Vivomixx in EU and Visbiome in USA to reduce anxiety and depression scores in mild to moderate active UC. It has been known that gut microbiota is associated with IBD and mental health. In addition, IBD patients complicated with psychiatric disorders are rising more and more attention. Further, a recent study "Probiotic Bifidobacterium longum NCC3001 Reduces Depression Scores and Alters Brain Activity: A Pilot Study in Patients With Irritable Bowel Syndrome" was published in Gastroenterology in 2017, thus we wonder if DSF have an effect on the depression/anxiety in patients with UC)A total of 60 patients will be randomly allocated into two groups, group A will receive standard medical therapy plus placebo (4 sachets/day,), and group B will receive standard medical therapy plus DSF (each sachet containing 450 billion CFU, eight bacterial strains 4 sachets/day) for 16 weeks. The primary endpoint is the reduction of anxiety and depression scores after treatment (at 8 weeks and 16 weeks) using hospital anxiety and depression scale (HADS). The secondary endpoints including clinical response after 8-week and 16-week treatment (measured by a ≥3-point reduction in a Simple Clinical Colitis Activity Index (SCCAI) score at 16 weeks), and clinical remission (defined as SCCAI score ≤5 at 8 weeks and 16 weeks). Changes in fecal-associated microbiota by 16S ribosomal RNA sequencing and metabolomics using company service following probiotics therapy (at 16 weeks) were also assessed, stratified by both change in SCCAI score following probiotics therapy and randomization. Adverse events were evaluated at week 8 and 16 weeks by patient survey

NCT ID: NCT04006080 Recruiting - Ulcerative Colitis Clinical Trials

Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis

FAVOUR
Start date: July 1, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to study the loss of vedolizumab in stool in patients with active ulcerative colitis (UC). Patients with moderate-to-severe UC who are commencing induction therapy with vedolizumab will be enrolled into a prospective study and stool will be collected for faecal vedolizumab measurement at days 1, 4 and 7; and again at weeks 2, 6 and 14. They will also be evaluated at three time-points (weeks 2, 6 and 14) for clinical and biochemical UC disease activity as well as serum vedolizumab concentrations and anti-vedolizumab antibodies.

NCT ID: NCT04004611 Completed - Ulcerative Colitis Clinical Trials

A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

SHINE-1
Start date: May 18, 2020
Phase: Phase 2
Study type: Interventional

This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 visits.

NCT ID: NCT04000139 Completed - Ulcerative Colitis Clinical Trials

Anthocyanin Rich Extract (ACRE) in Patients With Ulcerative Colitis

ACRE
Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy and safety of a bilberry derived anthocyanin-rich extract in patients with ulcerative colitis. Two thirds of participants will receive the anthocyanin-rich extract, while one third will receive placebo, for 8 weeks of treatment.

NCT ID: NCT03999294 Completed - Crohn Disease Clinical Trials

Bmgim Music Therapy Method in Reducing Stress in Patients With Inflammatory Bowel Disease

Start date: April 1, 2015
Phase: N/A
Study type: Interventional

Inflammatory bowel disease (IBD) is a term that defines a chronic disease characterized by inflammation of the intestine. It includes ulcerative colitis (UC) and Crohn's disease (CD). The objective of the study was to administer a treatment based on a group adaptation of the BMGIM in patients with inflammatory bowel disease (IBD) and assess its impact on state of mind, quality of life, anxiety, depression, immunocompetence as a marker of well-being, and levels of acute and chronic stress. To achieve the objectives a quasi-experimental, quantitative, qualitative, analytical, and prospective study was performed. 41 patients with IBD divided into a test group (24 patients), who received 8 sessions over 8 weeks, and a control group (17 patients). A saliva sample was taken from each patient before and after each session to determine cortisol levels (acute stress) and IgA (immunocompetence) using ELISA. A series of questionnaires were completed as follows: HADS (perceived anxiety), MOOD (state of mind), and CCVEII (quality of life). Similarly, a hair sample was taken before the first and after the last session to determine the cumulative cortisol level (chronic stress) using ELISA.