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Colitis clinical trials

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NCT ID: NCT06421818 Recruiting - Ulcerative Colitis Clinical Trials

Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis

Start date: May 2024
Phase: Phase 2
Study type: Interventional

Baitouweng Decoction is traditionally used to treat large intestine damp-heat syndrome of ulcerative colitis (UC) by oral administration and rectal enema.The project applicant's invention of transendoscopic entral tubing (TET) has been used in Baitouweng Decoction for the treatment of UC across the whole colon, however, the efficacy have not been reported and the underlying mechanism is still unclear. Compared with oral and rectal enema, Baitouweng Decoction by colon TET can improve the therapeutic effect by increasing the concentration of drugs in the whole colon, which need to be verified. This project will reveal the prescription effect and drug-microbiome interaction mechanism of whole colon repeated administration of Baitouweng Decoction in the treatment of UC through clinical randomized controlled studies, deep intestinal dynamic sampling, integrated analysis of multi-omics and TCM prescription metabolomics studies, and provide key scientific basis for the establishment of a new approach of whole colon repeated administration of TCM and a new strategy for the treatment of UC.

NCT ID: NCT06398808 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates

Start date: April 8, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of ZYIL1 oral capsule twice a day for 12 weeks for treatment of mild to moderate active ulcerative colitis resistant or intolerant to oral aminosalicylates.

NCT ID: NCT06372613 Recruiting - Clinical trials for Ulcerative Colitis in Histologic Remission

Association Between LRG and Histologic Remission in Ulcerative Colitis

Start date: February 25, 2024
Phase:
Study type: Observational

We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which can predict histologic remission in ulcerative colitis patients in this study. Colonoscopy with histology will be performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.

NCT ID: NCT06363383 Recruiting - Ulcerative Colitis Clinical Trials

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

Start date: May 9, 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 Recruiting - Colitis, Ulcerative Clinical Trials

Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis

Start date: April 1, 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: 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: NCT06324500 Recruiting - Clinical trials for Acute Severe Colitis

Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis

Start date: March 2, 2020
Phase:
Study type: Observational

ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC. BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC.

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: NCT06294925 Recruiting - Colitis, Ulcerative Clinical Trials

A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

EFFECT-UC
Start date: May 8, 2024
Phase:
Study type: Observational

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past. All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device. The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer. The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.

NCT ID: NCT06290934 Recruiting - Ulcerative Colitis Clinical Trials

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

SWIFT
Start date: March 27, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2). The primary objectives of this study are: Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12 Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12