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Colitis clinical trials

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NCT ID: NCT05753267 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Fenofibrate in Ulcerative Colitis

Start date: February 28, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent.

NCT ID: NCT05743374 Recruiting - Ulcerative Colitis Clinical Trials

Micronutrient and Additive Modifications May Optimize Diet To Health

Mammoth
Start date: April 2, 2024
Phase: N/A
Study type: Interventional

This is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the E 400-group with special respect to carragenan, CMC and polysorbates. At study start and end after one month their diet, clinical characteristics and microbiota will be analysed. The hypotheses are that their disease activity measured with calprotectin and their microbiota will improve after intervention.

NCT ID: NCT05743010 Recruiting - Ulcerative Colitis Clinical Trials

A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis

Start date: January 26, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 in patients with moderately to severely active UC. This study comprises 3 periods including screening period (D-28~D-1), treatment period (D1-D28), and safety follow-up period(D29-D58).

NCT ID: NCT05739864 Recruiting - Clinical trials for Active Ulcerative Colitis

Superdonor FMT in Patients With Ulcerative Colitis

Start date: February 13, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

In the last decades fecal microbiota transplantation (FMT) has been established as a highly effective option in the treatment of recurrent Clostridioides difficile infection (rCDI), with a success rate of nearly 90%. For this reason, it is recommended by international guidelines as a treatment option for this indication in clinical practice. Recently, a considerable body of evidences, suggest FMT as an effective and safe treatment in patients affected by Ulcerative Colitis (UC). In a recent meta-analysis of 324 subjects with UC, 30.4% of patients achieved both clinical and endoscopic remission after FMT compared to placebo (9.8%, P<0.00001). However, among the various published trials there is a fair variability in terms of methods and results, which are not comparable to those obtained in the rCDI. Nowadays, one of the most critical factors involved in the effectiveness of FMT in UC patients, is the choice of the donor. In addition, several studies have shown that some donors are associated with a higher clinical response rate than others. This hypothesis has been demonstrated in patients affected by irritable bowel syndrome, in which the use of a super-donor (a healthy person who has the predictive clinical and lifestyle characteristics of a healthy microbiota, and with a microbial profile associated with favorable clinical conditions) resulted in significantly higher clinical efficacy rates than placebo, similar to those obtained in rCDI (89%). Currently, studies that explored the efficacy of the super-donor FMT in UC patients are not yet available. Aim of this study is to investigate the efficacy of super - donor FMT, compared with placebo FMT, in the treatment of UC. The investigators will randomize adult patients with a recent diagnosis of UC to FMT from super - donors or placebo, by colonoscopy (first infusion) and capsules administration. Then, patients will be followed up 2 months after FMT.

NCT ID: NCT05739162 Recruiting - Obesity Clinical Trials

A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Start date: September 20, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese ulcerative colitis (UC) patients undergoing colectomy with eventual Ileal Pouch Anal Anastomosis (IPAA) compared to counseling on diet and lifestyle interventions alone.

NCT ID: NCT05735665 Recruiting - Clinical trials for Ulcerative Colitis Chronic Moderate

Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

UC (UC) is a chronic, relapsing and destructive inflammatory disorder of the colon which can lead to organ damage and impair quality of life. Consensus guidelines recommend to go beyond resolution of clinical symptoms and achieve endoscopic remission. This long-term treatment goal in UC is commonly defined by a Mayo endoscopic subscore < 13, and is associated with prolonged clinical remission, lower rates of hospitalization and lower rates of colectomy. However, colonoscopy is an invasive and expensive procedure, unpleasant to patients, not without risks, especially during severe flares. Moreover, CS is time-consuming and expensive for the Healthcare System. Clinical symptoms correlate well with endoscopic findings, and their improvement together to normalization of FC, are currently considered the short-term and intermediate-term targets to achieve. However, while asymptomatic patients with FC < 50 mcg/g have < 5% probability to have endoscopic lesions, and conversely patients with evident rectal bleeding and persistent increased stool frequency (> 3 stools above baseline) with FC > 250 mcg/g have less than 5% chance to have endoscopic remission, in patients in the intermediate scenarios with stool frequency score (SFS) 2 or 3 or rectal bleeding score (RBS) > 0, with FC values between 50 and 250 mcg/g, the uncertainty increases and CS should not be avoided. Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice8. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process9. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC10,11. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1 Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC14,15. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1.

NCT ID: NCT05733845 Recruiting - Ulcerative Colitis Clinical Trials

Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease

3TR
Start date: June 14, 2023
Phase: N/A
Study type: Interventional

Inflammatory bowel diseases (IBD) represent a group of immune-mediated disorders, in which currently unidentified trigger factors drive the manifestation of chronic relapsing- remitting destructive inflammatory episodes in the gut. IBD comprise two main disease entities, ulcerati\ie colitis (UC) and Crohn s disease (CD). The diseases differ in anatomical distribution, with continuous, uniform inflammation restricted to the colon in UC, and multifocal inflammation extended throughout the entire gastrointestinal tract from mouth to anus in CD. Clinical symptoms of IBD may include bloody stools, abdominal pain, fatigue, diarrhoea, fever and weight loss. Extra-intestinal symptoms occurring in up to 40% of patients, e.g. anaemia, skin lesions (e.g. erythema nodosum, pyoderma), arthritis and uveitis, and other complications directly related to the disease organ, such as fistula in CD are considered to reflect an overwhelming systemic inflammatory state. Disease onset typically manifests at age 15-35 years, men and women are almost equally affected. In addition, paediatric forms of IBD that often represent complex, se\/ere monogenic forms of the disease, are seen. The incidence rates of IBD in Europe are about 6.3 (CD) and 11.8 (UC) per 100.000 persons. With growing incidence rates and overall reduced mortality the lifetime prevalence of IBD is expected to rise. The estimated lifetime prevalence of 0.3%-0.5% of the European population corresponds to estimates of 1.5-2 million patients with IBD. Appropriate selection of therapies and their timing of introduction (decision support) in the course of IBD will be essential to reach a higher degree of disease control (across patients and within individual patients) than it is achie\led today. In many instances, comparati\ie data is missing and combinations or sequential therapies are not developed. In summary, despite some treatment successes, major challenges remain. The investigators have decided to include patients with inflammatory bowel disease (IBD) in which targeted therapies are administered as part of standard helathcare and which aims at identifiyng solid biomarker signatures as well as molecular pathways and mechanisms linked to response and non-response to therapy. Choice od medications (which are all approved for first line use) is by treating physicians. All follow-up procedures are according to standards of care.

NCT ID: NCT05731128 Recruiting - Colitis Ulcerative Clinical Trials

A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))

Start date: January 12, 2023
Phase: Phase 2
Study type: Interventional

The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active Ulcerative Colitis (UC) with an eosinophilic phenotype. Screening period: 2 to up to 4 weeks Treatment period: 52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.

NCT ID: NCT05704413 Recruiting - Colorectal Cancer Clinical Trials

Digestive Biobank for Exploring Microbiota-host Interactions

BiomHost
Start date: June 17, 2021
Phase:
Study type: Observational

Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.

NCT ID: NCT05702879 Recruiting - Ulcerative Colitis Clinical Trials

Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success

COMMIT
Start date: September 6, 2023
Phase:
Study type: Observational

The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.