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Colitis clinical trials

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NCT ID: NCT04013152 Active, not recruiting - Ulcerative Colitis Clinical Trials

Clinical Database of Colorectal Robotic Surgery

ROBOT CR
Start date: June 13, 2018
Phase:
Study type: Observational [Patient Registry]

Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

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: NCT04003818 Terminated - Clinical trials for Clostridium Difficile Infection-associated Diarrhea and Colitis

Efficacy and Safety of Teicoplanin in CDAD

Start date: May 15, 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis Secondary Objective: Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis

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.

NCT ID: NCT03998488 Completed - Ulcerative Colitis Clinical Trials

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

MINDFUL
Start date: January 31, 2020
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03996369 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 12
Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03986996 Terminated - Ulcerative Colitis Clinical Trials

Antimicrobial Therapy for Ulcerative Colitis (UC)

UC
Start date: July 25, 2019
Phase: Phase 2
Study type: Interventional

The Aim of this randoized controlled pilot study is to find a better treatment strategy for active UC based on the recent knowledge regarding the microbiota in UC and the beneficial or detrimental effects of antibiotics in restoring gut health and reducing inflammation. This study is designed to determine whether therapy with two antibiotics during a flare - amoxicillin and doxycillin, will be better than the current published antibiotic treatment combination using these antibiotics with metronidazole ( as the latter which may degrade beneficial species without adding benefit towards reducing pathobionts)