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Colitis, Ulcerative clinical trials

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NCT ID: NCT06267651 Not yet recruiting - Clinical trials for Early Detection of Complication of Ulcerative Colitis

Value Of ACE Index (Albumin, CRP And Endoscopy) In Predicting Intra Venous Steroid Response In Acute Severe Ulcerative Colitis In Assiut University Hospitals

Start date: January 2025
Phase:
Study type: Observational

1. Determine if the ACE index can predict resoponse to I V steroid in Acute severe ulcerative colitis 2. identify on admission a high-risk population who may beneft from earlier second line medical treatment or surgical intervention. ( steroid non responder groups )

NCT ID: NCT06249763 Not yet recruiting - Ulcerative Colitis Clinical Trials

Effects of Gluten Free Diet in Ulcerative Colitis

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

The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis, and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet. The main questions, the project aims to answer are: - What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis? - What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis? - What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms? During two study periods of one week each, participants will be eating gluten free supplemented with daily granola bars without and with high gluten content, respectively. During each active week, participants are asked to: - Eat gluten free and two daily granola bars delivered by the research team - Collect blood, stool and urine samples - Answer questionnaires about their symptoms, disease course, habitual lifestyle, and compliance to the protocol

NCT ID: NCT06228352 Not yet recruiting - Ulcerative Colitis Clinical Trials

Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis

ABRICO
Start date: March 2024
Phase:
Study type: Observational

Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis). Ulcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not fully understood. The decrease in the proportion of secondary bile acids, induced by microbiota dysbiosis in patients with UC could favor C. difficile infection. The main objective of the study is to describe the composition of bile acids (primary and secondary) in children followed for UC during relapse with or without CDI and to compare it to children with UC in remission and healthy controls. The composition of fecal microbiota will be also describe to correlate dysbiosis and bile acid abnormalities. And finally some fecal biomarkers will be study : short chain fatty acids, metabolic pathway of Tryptophan, and fecal Calprotectin.

NCT ID: NCT06213857 Not yet recruiting - Ulcerative Colitis Clinical Trials

Beneficial Effect of Silymarin in Ulcerative Colitis

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

The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with newly diagnosed Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians. Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The patients will be randomized based on hospital admission days into two groups: - Group Ⅰ (control group): 22 patients will receive mesalamine (4g\day induction & 2g\day maintenance) only for 6 months. - Group Ⅱ (silymarin group): 22 patients will receive mesalamine (4g\day induction & 2g\day maintenance) and silymarin (140 mg\day) for 6 months. The primary outcome will be clinical improvement defined as a 2 point or more decrease in the Mayo score from baseline. The secondary outcomes will be the change in the level of fecal calprotectin, superoxide dismutase and TNF-α.

NCT ID: NCT06188637 Not yet recruiting - Ulcerative Colitis Clinical Trials

Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study

ULTRAZ
Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

The ULTRAZ study is designed to better understand the mode of action of S1P receptor modulators. The alteration of leukocyte trafficking due to S1P receptors such as ozanimod is mainly investigated in rodent studies. Several previous studies show a reduced total leukocyte count in peripheral blood and only two study reported the effect of leukocyte subgroups before and after treatment with ozanimod. The change in leukocyte subgroups in peripheral blood as well as colonic mucosa and lymph nodes have not been investigated to our knowledge. Therefore, the aim of this study is to explore the changes in these three compartments.

NCT ID: NCT06176560 Not yet recruiting - Colitis, Ulcerative Clinical Trials

Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.

Start date: March 2024
Phase: Phase 3
Study type: Interventional

A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission.

NCT ID: NCT06143163 Not yet recruiting - Ulcerative Colitis Clinical Trials

Clinical Outcome of Treatment of Ulcerative Colitis in Adult

Start date: December 29, 2024
Phase:
Study type: Observational

1. characterize the response to current medical therapy in adult with ulcerative colitis . 2. Detect prognostic factors of response of biological therapy in adult with ulcerative colitis

NCT ID: NCT06126835 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants

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

The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.

NCT ID: NCT06116643 Not yet recruiting - Ulcerative Colitis Clinical Trials

Pilot Study of a New Medical Food in the Management of Ulcerative Colitis

Start date: December 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to determine at how well a new medical food works in managing inflammation associated with ulcerative colitis in children. The main question it aims to answer is: 1) How well does the new medical food lower an inflammatory biomarker known as fecal calprotectin (fCal) in ulcerative colitis as compared to the historical active therapy levels of fCal? Participants will take a specified dose of the medical food in water each day for 12 weeks. The level of fCal will be measured through a stool sample at baseline, one during the 12 weeks, at the end of 12 weeks, and once more at 16 weeks. The levels of fCal will be compared across the 16 weeks and compared with levels before the new medical food was taken.

NCT ID: NCT06100289 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Start date: September 30, 2024
Phase: Phase 3
Study type: Interventional

The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. During the study, participants will visit their study clinic several times.