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Colitis clinical trials

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NCT ID: NCT05488041 Recruiting - Ulcerative Colitis Clinical Trials

Anal Manometry Examination in Patients With Ulcerative Colitis

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), are chronic immune-related diseases. IBD symptoms frequently overlap with symptoms of functional GI disorders such as irritable bowel syndrome (IBS) and defecatory disorders, and these symptoms are common in patients with active disease, and also in quiescent disease. Underdiagnosis of abnormal anorectal function may result in an inappropriate escalation of IBD therapy. In this study, the investigators aim to evaluate if damage from chronic inflammation in UC results in anorectal damage such as hypersensitive, hyperactive, poorly compliant rectum, and hypotensive sphincter. If this is the case, early aggressive treatment of the disease is needed. Another important point in this study is to find out which of the anorectal symptoms are due to a hypersensitive, hyperactive, and poorly compliant rectum and not due to mucosal inflammation. The diagnosis of abnormal anorectal function via manometry may help to give the appropriate treatment, such as biofeedback or pharmacological treatment such as loperamide or tricyclic anti-depressants. This may avoid escalation or replacing effective IBD therapy unnecessarily.

NCT ID: NCT05486104 Recruiting - Clinical trials for Moderate to Severe Ulcerative Colitis

Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis

Start date: November 8, 2022
Phase: Phase 2
Study type: Interventional

This study is a multicenter, randomized, double-blind study. There are three dosage groups: Hemay005 45 mg BID group, 60 mg BID group or placebo group, with 36 patients in each dosage group. All patients will enter a 12-week double-blind treatment period. All subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.

NCT ID: NCT05481619 Recruiting - Ulcerative Colitis Clinical Trials

Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

Inflammatory bowel disease is a group of chronic, non-specific inflammatory diseases of the intestinal tract whose etiology has not yet been fully elucidated, including ulcerative colitis and Crohn's disease. Vedolizumab, a novel biologic agent, is a recombinant humanized monoclonal antibody that specifically antagonizes intestine-selective α4β7 integrins on the surface of leukocyte subsets, thereby preventing migration of leukocyte subsets from the blood to the intestinal mucosa and reducing local inflammation in the gut. In this study the investigators propose to build on an existing cohort and analyse, by means of a multi-omics approach, the baseline gut microbial composition and abundance, intestinal and serum metabolome characteristics of UC patients and their changes during treatment, to predict the functional mechanisms by which these changing characteristics influence the therapeutic response to vindolizumab.

NCT ID: NCT05479617 Recruiting - Ulcerative Colitis Clinical Trials

Personalised Prediction Of Disease Course In Ulcerative Colitis Using Multimodal Machine Learning - Part Of The Presager Project

Presager II
Start date: June 20, 2022
Phase:
Study type: Observational

In patients achieving clinical remission following a flare, artificial intelligence can reliably predict a new flare within the next 12 months utilizing clinical and objective information at day 0 and week 8. Secondary endpoints: - An artificial intelligence model's precision in predicting a new flare within 2 and 3 years - An artificial intelligence model's precision to rule out patients who will not experience a new flare within 1, 2 and 3 year

NCT ID: NCT05466890 Recruiting - Ulcerative Colitis Clinical Trials

Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC)

PL8177-205
Start date: September 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8177 and look at the improvement and healing of the intestine after 8 weeks of treatment. The study will include adult males and nonpregnant, nonlactating females with acute Ulcerative Colitis (UC).

NCT ID: NCT05456893 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies

ImmUniverse
Start date: July 28, 2022
Phase:
Study type: Observational

UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification. The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).

NCT ID: NCT05456412 Recruiting - Colitis, Ulcerative Clinical Trials

JAK Inhibition in Ulcerative Colitis

Start date: December 20, 2022
Phase: N/A
Study type: Interventional

The treatment for Ulcerative Colitis (UC) aims to achieve and maintain remission and is usually lifelong and expensive. Current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over time (secondary non-response). There is now growing evidence that there is substantial interpatient variation in the composition of the inflammation associated network of immune cells. A deeper knowledge of the patient's alterations in the mucosal immune response would help identify key drivers of inflammation and select the appropriate therapy. By analyzing the changes in the composition of immune cells induced by Janus Kinase (JAK) inhibition, we aim to obtain a better insight into the mechanistic effects of JAK inhibition and the downstream effects. These mechanistic insights are needed to identifying potential responders and non-responders in the future.

NCT ID: NCT05447572 Recruiting - Ulcerative Colitis Clinical Trials

FIT Combining FC for Predicting MH and Histology Remission in UC

Start date: September 1, 2021
Phase:
Study type: Observational [Patient Registry]

Investigaters will perform a clinical trial to asess the abilitiy of qFIT and FC on predicting UC MH and histology remission.

NCT ID: NCT05442567 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Start date: May 16, 2023
Phase: Phase 3
Study type: Interventional

The study is an extension of two parent studies (MLN0002-3024 [NCT04779307] and MLN0002-3025 [NCT04779320]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

NCT ID: NCT05431283 Recruiting - Ulcerative Colitis Clinical Trials

Real-world Effectiveness of Tofacitinib on Ulcerative Colitis Associated Spondyloarthropathy

RETUCAS
Start date: April 25, 2022
Phase:
Study type: Observational

Tofacitinib (TOFA) is a JAK inhibitor already used in rheumatology for the treatment of moderate-to-severe active rheumatoid arthritis and psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease- modifying antirheumatic drugs. Furthermore, TOFA has been recently approved for the treatment of adult patients with moderate-to-severe active Ulcerative Colitis (UC) who had no response, lose response, or were intolerant to either conventional therapy or a biologic agent. The approval was based on the efficacy demonstrated by TOFA in three phase 3 randomized controlled trials named OCTAVE: two identically designed, 8-week, placebo- controlled, induction studies of oral TOFA 10 mg twice daily followed by the OCTAVE Sustain 52-week maintenance study. About sacroiliitis, 2 out of 8 patients treated with TOFA improved after 8 weeks, compared with 0 out of 3 patients in the placebo group. Obviously, these data should be interpreted with extreme caution since patient numbers were very low, and it should be again emphasized that these trials were not designed to explore the efficacy of TOFA onextraintestinal manifestations. On these premises, we designed a prospective, multicenter, observational, 52-week study with the aim of assess the effectiveness of TOFA on UC-associated spondyloarthropathy.