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Colitis, Ulcerative clinical trials

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NCT ID: NCT05321485 Recruiting - Ulcerative Colitis Clinical Trials

The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD

MEDICATION
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

Medication non-adherence is an existing problem in patients with inflammatory bowel diseases (IBD). Adherence rates are especially low in children and adolescents. Good medication adherence is key in achieving lower disease activity and longer periods of remission. Previous research has shown education can increase medication adherence. MedicijnWijs is a mobile phone app containing a module concerning a 6-weeks guidance with azathioprine therapy. It provides information about IBD and azathioprine. In this multicenter before-and-after study, the aim is to assess the effect of MedicijnWijs on the adherence to azathioprine therapy in adolescents with IBD. This is done using two validated questionnaires that are translated to Dutch: the Medication Adherence Report Scale-5 (MARS-5), which tests the participants' adherence to azathioprine therapy, and the Inflammatory Bowel Disease Knowledge Inventory Device 2 (IBD-KID2), which tests the participants' knowledge about IBD. These questionnaires are filled in at the beginning of the study period and after 6 weeks of using MedicijnWijs. This way a change in both scores can be assessed. The investigators hypothesize that MedicijnWijs will help increase the adherence to azathioprine therapy in adolescents with IBD.

NCT ID: NCT05316584 Recruiting - Ulcerative Colitis Clinical Trials

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

ASSIST
Start date: September 6, 2022
Phase: N/A
Study type: Interventional

The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. The investigators will address the following specific aims: 1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care. 2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care.

NCT ID: NCT05313620 Recruiting - Ulcerative Colitis Clinical Trials

Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events

Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa). In the case of the group of patients treated with tofacitinib, the selection will be made following the action protocol implemented in our center, in which this drug is usually reserved for those cases refractory to anti-TNFα and/or vedolizumab. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.

NCT ID: NCT05294107 Recruiting - Crohn Disease Clinical Trials

Intestinal Organoids

BIOÏDES
Start date: September 6, 2022
Phase: N/A
Study type: Interventional

Over the last decade, the use of mini-organ or organoids has been increasingly developed in fundamental research. Indeed, digestive organoids represent an essential advance compared to classical culture systems (epithelial cell lines, immortalized cells) since they preserve in culture the functional complexity present in vivo (architecture, different cell types). They also have the advantage of being able to be propagated indefinitely (unlike explants), minimizing the use of animal models and reducing the amount of tissue required. Finally, their growth and development depends on the origin of the sample (the organoid will develop differently if the cell source comes from a patient suffering from an inflammatory bowel disease, for example), thus generating models of human pathologies to better determine their physiopathology. The use of organoids in biomedical research has proven to be an indispensable tool for the understanding of cellular and molecular mechanisms involved in epithelial renewal and the screening of molecules and ingredients for applications in the health and agri-food sectors.

NCT ID: NCT05287126 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Start date: December 16, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whichever comes first.

NCT ID: NCT05271838 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Protein and Magnesium in Ulcerative Colitis

PAMUC
Start date: February 8, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to improve the quality of nutritional therapy for patients admitted with Acute Severe Ulcerative Colitis (ASUC) treated with high-dose steroids. This study consists of two randomized interventions and one observational part regarding protein, magnesium, and metabolic stress. First an interventional part aims to explore the effect of a high-protein diet during and after admission on different parameters regarding protein turnover.Second the study aims to explore the degree of magnesium depletion in ASUC. In case of magnesium depletion, the study aims to investigate whether oral magnesium supplementation can regain body stores of magnesium. Last the study aims to observe the degree of metabolic stress, including, the degree of insulin resistance, in ASUC during admission and under treatment with high-dose steroids compared to three weeks after discharge.

NCT ID: NCT05271773 Recruiting - Clinical trials for UC - Ulcerative Colitis

Impact of Therapeutic Intervention on Quality of Life in Patients With Ulcerative Colitis

CAVI_CU
Start date: November 18, 2022
Phase:
Study type: Observational

This study is therefore postulated as a clear alternative that evaluates patients´quality of life, and recognises fecal calprotectin as an inflammatory marker. Longitudinal, prospective, multi-center cohort study to measure the impact that the therapeutic attitude (treatment intensification/de-intensification o escalation/de-escalation) has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing (Mayo 0, Mayo 1); considering as treatment intensification/de-intensification a dose increase or decrease on the same line of treatment, and escalation/de-escalation if there is a change to a new line of treatment.

NCT ID: NCT05242484 Recruiting - Colitis, Ulcerative Clinical Trials

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

DUET-UC
Start date: September 19, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

NCT ID: NCT05239702 Recruiting - Ulcerative Colitis Clinical Trials

Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases

Start date: February 28, 2022
Phase: Early Phase 1
Study type: Interventional

A Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune Diseases

NCT ID: NCT05230875 Recruiting - Ulcerative Colitis Clinical Trials

Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial

SexIA-CT
Start date: April 7, 2022
Phase:
Study type: Observational

Patients with Inflammatory Bowel Disease (IBD) have higher rates of sexual dysfunction than the general population. We offer an educational program on IBD including a specific discussion on intimacy and sexuality for IBD patients. Our objective is to investigate the benefit of this intervention on sexual function in patients with IBD.