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Colitis, Ulcerative clinical trials

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NCT ID: NCT04401605 Recruiting - Ulcerative Colitis Clinical Trials

Fermented Food-Supplemented Diet in Ulcerative Colitis

Start date: September 14, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04398550 Recruiting - Ulcerative Colitis Clinical Trials

SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis

Start date: September 3, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04373473 Recruiting - Clinical trials for Adults With Ulcerative Colitis

Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

Start date: September 14, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.

NCT ID: NCT04372108 Recruiting - Crohn Disease Clinical Trials

A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

Start date: June 24, 2021
Phase:
Study type: Observational

The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).

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: 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: NCT04272307 Recruiting - Clinical trials for Inflammatory Bowel Diseases

MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach.

ITAC
Start date: May 14, 2020
Phase:
Study type: Observational

This pilot prospective study will investigate the role of microbiota and known enteropathogens in Acute Severe Ulcerative Colitis (ASUC). Investigators will compare a group of patients hospitalized for an ASUC with patients experiencing a Non-Severe Ulcerative Colitis (NSUC) flare by investigating microbiome, metabolome and transcriptome and integrating this data through a multi-omic framework. This systems biology approach aims at enhance our understanding of this severe event, define diagnosis and prognosis biomarkers to improve medical therapy and avoid colectomy and/or death.

NCT ID: NCT04231110 Recruiting - Ulcerative Colitis Clinical Trials

Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis

Start date: May 1, 2021
Phase: Phase 4
Study type: Interventional

This is a pilot study of combination therapy using FMT and vedolizumab for induction of UC. The investigators hypothesize that a combination therapy approach which addresses immune trafficking and microbial manipulation simultaneously will lead to superior outcomes than those seen with single agent therapy.