Clinical Trials Logo

Crohn Disease clinical trials

View clinical trials related to Crohn Disease.

Filter by:
  • Enrolling by invitation  
  • Page 1 ·  Next »

NCT ID: NCT06381518 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease

SHUFFLE
Start date: March 12, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator. Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks. The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch.

NCT ID: NCT06146335 Enrolling by invitation - Crohn Disease Clinical Trials

Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.

NCT ID: NCT05994716 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Telemonitoring for IBD Goodness Examination in Russia

TIGE-Rus
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

This is a prospective, randomized study to assess the impact of telemedicine (telemonitoring, tele-education and tele-consultation) on the patients with Inflammatory Bowel Disease (IBD). The main study objective is to evaluate the impact of telemedicine on the quality of life in IBD. The secondary study endpoints are to determine disease activity, the number of IBD relapses, to investigate rate of leukopenia in patients taking azathioprine, to determine medication adherence, psychological well-being and satisfaction with medical care in the telemedicine group in comparison with the face-to-face follow-up group. Moreover, we aim to evaluate association between secondary outcomes and QoL. It is planned to enroll 64 patients. The study duration is 18 months (12 months - patient enrollment, 6 months - telemonitoring). The study consists of 3 stages. The first stage is selection of patients with IBD after treatment in the gastroenterology department. The second stage is face-to-face appointment and general recommendations (for the observation group); monthly completion of questionnaires on the web-platform, possibility to contact with doctor via chat or phone call, access to educational information; a monthly phone call to each patient from to answer any questions or concerns they may have and to interview them according to the checklist (for the intervention group). The third stage is the evaluation of IBD activity (re-hospitalization after 6 months), number of IBD relapses, quality of life, frequency of leukopenia in patients receiving azathioprine therapy, medication adherence, psychological well-being and satisfaction with medical care.

NCT ID: NCT05918562 Enrolling by invitation - Clinical trials for Gastrointestinal Diseases

Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep

Start date: April 20, 2021
Phase: N/A
Study type: Interventional

This study is designed to evaluate if pediatric patients who are undergoing a bowel preparation in anticipation of a colonoscopy may be able to take in a low fiber diet instead of a standard, clear liquid diet, while still accomplishing an adequate bowel prep.

NCT ID: NCT05386290 Enrolling by invitation - Ulcerative Colitis Clinical Trials

A Multicentered Prospective Cohort Study of Chinese IBD Patients

Start date: July 9, 2020
Phase:
Study type: Observational

Inflammatory bowel disease(IBD), including ulcerative colitis (UC) and Crohn's disease (CD), is characterized by chronic and recurrent nonspecific intestinal inflammation with high disability rate. During the past few decades, the prevalence of IBD is increasing, especially in developing countries, which brings great burden to patients themselves and medical insurance. Currently, biological medications such as TNFα inhibitors (infliximab, adalimumab, etc.), integrin receptor antagonist (vedolizumab) and interleukin 12/interleukin 23 inhibitor (ustekinumab) are commonly used in IBD treatment as well as traditional drugs such as glucocorticoid, immunosupressive agents and 5-Aminosalicylic Acid, and surgury. However, health-econimic analysis is lacking in Chinese IBD patients and more research is needed for making treatment choice. Meanwhile, the etiology, disease progression and prognosis prediction has not totally been clarified. The efficacy prediction model of vedolizumab and infliximab has been analyzed, whose prediction markers include level of albumin, smoking, surgery history, fistula, etc. However, no model has included predictors concerning disease pathway or pharmacological pathway in patients accepting different therapy. So a model to predict IBD progression and prognosis concerning pharmacological pathway is going to be explored.

NCT ID: NCT05203926 Enrolling by invitation - Sacroiliitis Clinical Trials

Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

This study aims to further define and characterize imaging findings of possible sacroiliitis in Crohn's Disease patients by recalling subjects who had findings of possible sacroiliitis on prior MRE and assess the natural history and outcome of these cases by using standard magnetic resonance imaging (MRI) and x-ray of the sacroiliac joints.

NCT ID: NCT04939337 Enrolling by invitation - Crohn's Disease Clinical Trials

A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.

Start date: November 12, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.

NCT ID: NCT04835506 Enrolling by invitation - Ulcerative Colitis Clinical Trials

Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial

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

The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease.

NCT ID: NCT04646187 Enrolling by invitation - Crohn Disease Clinical Trials

De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease

FREE
Start date: March 11, 2021
Phase: Phase 4
Study type: Interventional

BACKGROUND/RATIONALE: Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied. OBJECTIVE: To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval.

NCT ID: NCT04456517 Enrolling by invitation - Crohn's Disease Clinical Trials

Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy

REACT
Start date: October 18, 2022
Phase: Phase 2
Study type: Interventional

Crohn's disease is an inflammatory disorder that can affect any part of the gastrointestinal (GI) tract. Some patients still experience persistent diarrhea or other symptoms such as abdominal pain even when their Crohn's disease is in remission. Diarrhea and/or abdominal pain that is not responsive to standard therapies can significantly affect a patient's quality of life and ability to work. The purpose of this study is to test the safety and effectiveness of the drug ranolazine in reducing Crohn's disease-associated diarrhea and other symptoms. Ranolazine is approved by the US Food & Drug Administration (FDA) for chronic angina (a heart condition). This study is investigating if ranolazine could be used in the setting of Crohn's disease.