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Colitis, Ulcerative clinical trials

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NCT ID: NCT06363383 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants

Start date: April 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy volunteers. The main questions it aims to answer are: Is the drug safe when administered orally at increasing doses? Researchers will compare the drug with placebo to see if there are more side effects in those receiving the drug. Participants will receive a single or five daily doses of the drug or placebo and will be asked to stay in the clinic for five days following the last dose.

NCT ID: NCT06359808 Not yet recruiting - Colitis, Ulcerative Clinical Trials

Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis

Start date: April 2024
Phase:
Study type: Observational

Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients.

NCT ID: NCT06353828 Active, not recruiting - Ulcerative Colitis Clinical Trials

Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients

Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation, including IBD models. Based on positive safety and initial efficacy profiles of CBD found in IBD animal and clinical studies, the main aim of this study is to evaluate the safety, tolerability and efficacy of a novel enema formulation of CBD for the treatment of active ulcerative proctitis.

NCT ID: NCT06352515 Not yet recruiting - Ulcerative Colitis Clinical Trials

T Lymphocyte Subsets in Ulcerative Colitis

Start date: June 1, 2024
Phase:
Study type: Observational

1. Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients. 2. Correlation of T-cell subsets to therapeutic response/ disease activity. 3. Assess the value of circulating IgG anti-Integrin αvβ6 in UC.

NCT ID: NCT06351696 Recruiting - Ulcerative Colitis Clinical Trials

The Effects of Bromelain Supplement in Patients With Ulcerative Colitis

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks. IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention.

NCT ID: NCT06338930 Not yet recruiting - Crohn Disease Clinical Trials

Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy

ROADMAP
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. However, many of these patients do not require additional interventions from the IBD specialist during these visits. In addition, patients in long-term remission, often request a less frequent follow-up in the hospital and in consequence a less frequent absence from school or work. In conclusion, these routinely follow-up visits might put unnecessary burden on both healthcare providers and IBD patients, as well as on healthcare resources. Until now, no clear standard was set for how to organize a remote monitoring programme that is feasible and safe in a large patient population. Despite the possible added value of remote monitoring for IBD patients on stable or no therapy and who are in remission, they are seldomly the targeted population in clinical trials analysing the effects of remote monitoring in IBD. Secondly, a significant reduction in outpatient clinic visits, is often not actively included in the programme, but more an outcome result. Finally, to compose a safe remote monitoring programme, subjective and objective parameters of disease activity should be collected. With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags.

NCT ID: NCT06335160 Not yet recruiting - Ulcerative Colitis Clinical Trials

Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine

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

To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine

NCT ID: NCT06331637 Not yet recruiting - Ulcerative Colitis Clinical Trials

Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis

TTSS-Pouch
Start date: July 31, 2024
Phase:
Study type: Observational

This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)

NCT ID: NCT06311123 Recruiting - Ulcerative Colitis Clinical Trials

Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis

Start date: October 6, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are: 1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration. 2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity. Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod. Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration.

NCT ID: NCT06306261 Not yet recruiting - Ulcerative Colitis Clinical Trials

Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis

TIMAEUS
Start date: March 15, 2024
Phase:
Study type: Observational

The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.