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Crohn's Disease clinical trials

View clinical trials related to Crohn's Disease.

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NCT ID: NCT06299631 Completed - Crohn's Disease Clinical Trials

Endoscopic Relapse Risks Evaluation After Ileocolic Resection for Crohn's Disease

RIC-1
Start date: January 2015
Phase:
Study type: Observational

Aim of the study: To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents. Methods: From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected. Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period. Short and long-term outcomes were compared between the two groups. Primary outcome: Endoscopic recurrence (defined as > i2 lesions according to Rutgeerts classification) 6 months after surgery

NCT ID: NCT06274554 Not yet recruiting - Crohn's Disease Clinical Trials

Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease

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

The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to or are undergoing standard of care treatment with an IL-23 therapy for their Crohn's disease. The main question it aims to assess is will patient response to IL-23 therapies improve when simultaneously treated with fluconazole.

NCT ID: NCT06249555 Recruiting - Crohn's Disease Clinical Trials

VOICE-Early Response to Vedolizumab and Ustekinumab in Participants With Crohn's Disease: A Prospective Observational Study

VOICE
Start date: March 20, 2024
Phase:
Study type: Observational

The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.

NCT ID: NCT06244849 Not yet recruiting - Crohn's Disease Clinical Trials

TOward a Better Understanding of the autoPhagy Machinery for the Identification of Potential Novel Biomarkers and Therapeutic Targets in Crohn's Disease - TOPIC Study

TOPIC
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Crohn's disease (CD) belongs to chronic inflammatory bowel diseases (IBD) affecting over 2 million individuals in the North America and 3.2 million in Europe with an increasing incidence rate in newly industrialized countries experiencing a westernization of lifestyle (1). This highly disabling disease affects patients' life in several ways with severe complications requiring surgery for half of them and is responsible for considerable economic burdens (2,3). Decades of research displayed that CD pathogenesis is determined by inappropriate immune responses towards luminal microbiota in genetically susceptible hosts. Genome-wide association studies (GWAS) have identified autophagy as one of the main pathways associated with susceptibility to CD (4-6). Autophagy is a dynamic process of the lysosomal catabolism, called autophagy flux, which is crucial to degrade and recycle obsolete and deleterious cytosolic components of the cell (7). Autophagy is also the main cell-autonomous process to fight intracellular microorganisms by degrading them, and by contributing to antimicrobial host immune responses. However, the functional consequences of polymorphisms affecting autophagy-associated genes on the dynamic process of autophagy and its real impact on CD pathogenesis remain largely unknown. In addition, CD is associated with a gut microbiota dysbiosis, as exemplified by the higher prevalence of AIEC (a bacterium eliminated by autophagy) in ileal mucosa of CD patients (8-10). Hence, autophagy defect, linked to autophagy SNPs, could contribute to CD-related dysbiosis and to CD activity and severity. Beyond, CD-associated abnormalities of the autophagy flux may affect the composition of the autophagic cargoes, as well as the one of other vesicular pathway, such as exosomes, known to influence autophagy. These impairments could affect at longer term both cell activities and immune responses, especially in antigen presenting cells, which drive host immune responses. The TOPIC project concerns translational research, in which we plan to generate a prospective cohort of CD patients giving up the unique opportunity to collect clinical data, to analyse simultaneously the autophagy flux, genetic variants of interest (from blood samples) and intestinal microbiota (from intestinal samples) and allowing to perform more fundamental studies. The results of the fundamental part will allow a better understanding of the pathophysiology of CD, and ultimately better management of these patients.

NCT ID: NCT06233461 Recruiting - Crohn's Disease Clinical Trials

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

Start date: March 5, 2024
Phase: Phase 2
Study type: Interventional

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.t

NCT ID: NCT06227910 Not yet recruiting - Crohn's Disease Clinical Trials

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

VICTRIVA
Start date: July 22, 2024
Phase: Phase 3
Study type: Interventional

The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.

NCT ID: NCT06226883 Recruiting - Crohn's Disease Clinical Trials

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

GARNET
Start date: April 4, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

NCT ID: NCT06211400 Not yet recruiting - Crohn's Disease Clinical Trials

Vibration Exercise for Crohn's to Observe Response

VECTOR
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Background: Crohn's disease (CD) is a long-term inflammatory condition of the digestive system. People with CD often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. In addition, they require long-term treatment with frequent negative effects and often need surgery and hospitalisations. Therefore, people with CD report a lower health-related quality of life (HRQOL) compared with other people. Doctors are constantly trying to find new treatments to improve HRQOL and control symptoms and whole body vibration exercise could be a potential treatment. Exercise might be a simple, safe, and low-cost intervention for improving HRQOL in people with CD. This is because it has the potential to improve several aspects of physical, mental and social well-being simultaneously. Adults with CD have been shown to be less active than the general population and do not meet the recommended daily physical activity guidelines. One barrier to exercise is lack of time, however whole-body vibration exercise (where you stand and squat on a vibrating plate) can be done over a much shorter duration and at a lower intensity to gain potentially similar or at times greater benefits. More research is needed to understand the effects, both positive and negative of vibration exercise in people with CD. Aim: This study begins to understand whether undertaking a supervised 6-week vibration exercise programme for adults with mild to moderately active Crohn's disease improves HRQoL and other symptoms such as fatigue.

NCT ID: NCT06180382 Not yet recruiting - Crohn's Disease Clinical Trials

Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.

VEDIAN
Start date: June 2024
Phase: Phase 4
Study type: Interventional

A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class. Moreover, according to STRIDE 2 recommendations and CALM study, optimize patients based solely on lack of biological remission (CRP, calprotectin) can be discuss. If CALM study has showed that the intervention arm based on regular monitoring fecal calprotectin, CRP and/or CDAI to optimize patients under adalimumab was significantly associated to an increase rate of mucosal healing that the standard of care strategy based on only clinical activity, TDM was not available to guide drug optimization strategy.

NCT ID: NCT06126146 Completed - Crohn's Disease Clinical Trials

An Observational Study to Assess Participant-Reported Real-World Experience of Risankizumab On-body Injector (OBI) for the Treatment of Crohn's Disease in Adult Participants in the United Kingdom (UK)

COMMODUS
Start date: October 26, 2023
Phase:
Study type: Observational

Crohn's Disease (CD) is a chronic condition that causes inflammation of the gastrointestinal tract or gut. This study will assess real-world, adult participant experience of self-injection with the risankizumab OBI. Risankizumab is an approved drug for the treatment of CD in adults. Approximately 80 participants who are prescribed risankizumab by their doctors and are transitioning from the pre-filled syringe (PFS) to the use of OBI will be enrolled in this study in the United Kingdom (UK). Participants will receive risankizumab OBI as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 6 months. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site, at home, or virtually as per standard of care.