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Colitis, Ulcerative clinical trials

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NCT ID: NCT04434872 Terminated - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Start date: July 2015
Phase: Phase 2
Study type: Interventional

Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT). FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability. Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm. At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level. Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.

NCT ID: NCT04424303 Recruiting - Ulcerative Colitis Clinical Trials

Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

TOFAST
Start date: December 4, 2020
Phase:
Study type: Observational

This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

NCT ID: NCT04411784 Completed - Clinical trials for Inflammatory Bowel Diseases

PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis

PROTECT-ASUC
Start date: May 20, 2020
Phase:
Study type: Observational

Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the COVID pandemic are widespread, and whether they have any impact on patient outcomes

NCT ID: NCT04408703 Not yet recruiting - Ulcerative Colitis Clinical Trials

PRognOstiC valuE of rEd Density in Ulcerative Colitis

PROCEED-UC
Start date: June 2020
Phase:
Study type: Observational

Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.

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: NCT04360343 Completed - Ulcerative Colitis Clinical Trials

Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects

Start date: July 1, 2020
Phase: Phase 1
Study type: Interventional

To compare the pharmacokinetics, pharmacodynamics and safety/tolerability of LC51-0255 film-coated tablet (SG85) with LC51-0255 uncoated tablet (SG82) in healthy subjects.

NCT ID: NCT04353791 Completed - Clinical trials for Ulcerative Colitis Chronic Moderate

Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis

Start date: September 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase Ib/IIa to evaluate the safety and tolerability of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis over 28 days. This trial will also explore pharmacokinetics (PK) profile and preliminary therapeutic efficacy associated with OST-122 through biomarker analysis and clinical, endoscopic and histologic assessments.