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Intestinal Diseases clinical trials

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NCT ID: NCT06453317 Not yet recruiting - Ulcerative Colitis Clinical Trials

Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis

COMBO-UC
Start date: July 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. The main questions it aims to answer are: Does the combination therapy improve the symptoms and heal the intestine quicker and better than these drugs administered alone? Does the combination therapy improve the quality of life better than these drugs administered alone? What medical problems do participants have when taking the combination therapy? Participants: Patients diagnosed with UC will be qualified to biologic therapy (infliximab/ustekinumab/infliximab + ustekinumab). Visit the clinic in stated periods for assessment and to apply medication. Take drugs based on the schedule.

NCT ID: NCT06439641 Not yet recruiting - Ulcerative Colitis Clinical Trials

Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease

SOMMICI
Start date: July 2024
Phase: N/A
Study type: Interventional

Inflammatory bowel diseases (IBD) including Crohn's disease (CD) and ulcerative colitis (UC), are an inflammatory disease that can affect the entire digestive tract from the mouth to the anus for CD and the entire colon and rectum for UC. They mainly affect adolescents and young adults. These pathologies evolve in relapses interspersed with phases of remission. Sometimes associated with extraintestinal manifestations (joint, dermatological, ophthalmological or biliary systems), chronic inflammation of the digestive tract and the resulting symptoms (abdominal pain, diarrhea, rectal syndrome, etc.) lead to a significant alteration in the quality of life of patients in all spheres of activity (professional, sexual, social). Sleep is a basic neurophysiological state, the normal total duration of which in humans is between six and ten hours per day. It is an essential element of the circadian rhythm in humans, influencing certain cellular functions and in particular the synthesis of cytokines and pro-inflammatory molecules (Nobel Prize in Medicine awarded to Jeffrey C. Hall, Michael Rosbash and Michael W. Young in 2017). Sleep disturbances and disruption of the circadian rhythm lead to metabolic and immunological dysfunctions, which may be involved in chronic inflammatory conditions through changes in the immune response. In the field of IBD, many studies suggest poor sleep quality in patients with IBD. While there seems to be a link between sleep disorders and impaired quality of life with a socio-professional impact in these patients, the links between IBD activity, its treatment and sleep disorders are poorly studied, with discordant results in previous studies. In order to enrich our knowledge on this topic, the investigators wish to study the prevalence and risk factors associated with sleep disorders in IBD patients in order to improve patients' quality of life

NCT ID: NCT06427135 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBD

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

This project is a multimodal wearable device-based evaluation of the efficacy of an exercise prescription intervention for inflammatory bowel disease in a This is a single-center, randomized controlled clinical study to evaluate the efficacy of an exercise prescription intervention in inflammatory bowel disease based on multimodal wearable devices. The experimental group was treated with exercise intervention therapy on top of the existing medication.

NCT ID: NCT06424769 Not yet recruiting - Ulcerative Colitis Clinical Trials

Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management

PROMOTE IBD
Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn whether IBD patients have better disease outcomes and feel more empowered to manage their condition if they have access to text messaging with their clinical team and if their symptoms are more regularly monitored through text-based surveys. Researchers will compare participants who have access to text-based monitoring, communication and education to participants who have access to text-based education alone. Researchers will also examine if different social and other non-medical factors impact IBD symptoms and quality of life. All participants will: - complete 5 brief on-line surveys over 12 months about their IBD and social risk factors, - receive IBD education content by text message up to 2 times a week. Some participants will also: - receive additional surveys by text to monitor their IBD progression, - have the opportunity to directly text message their IBD medical team.

NCT ID: NCT06405503 Not yet recruiting - Clinical trials for Inflammatory Bowel Disease

Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease

Start date: June 1, 2024
Phase:
Study type: Observational

A thorough discussion of treatment options to manage inflammatory bowel disease (IBD), including the risks and benefits of each class of medication, can be a complex discussion and time consuming. Having to use a translator adds an additional layer of time and complexity to these discussions as well as potential misunderstanding. Further, in addition to language, cultural differences can also play into treatment acceptance. This study aims to determine the impact of primary language on the selection of treatment for IBD and on disease outcomes.

NCT ID: NCT06393881 Not yet recruiting - Clinical trials for Gastro-Intestinal Disorder

A Study to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of UI059 and UIC202201

Start date: July 3, 2024
Phase: Phase 1
Study type: Interventional

A randomized, open-label, multiple-dose crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers

NCT ID: NCT06382519 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Thalidomide Therapy for VEOIBD

Start date: May 15, 2024
Phase:
Study type: Observational

This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease

NCT ID: NCT06342011 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease

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

For the first time, this study developed an anti-inflammatory diet (AID) recipe suitable for Inflammatory bowel disease(IBD) patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients.

NCT ID: NCT06338930 Not yet recruiting - Crohn Disease Clinical Trials

Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy

ROADMAP
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. However, many of these patients do not require additional interventions from the IBD specialist during these visits. In addition, patients in long-term remission, often request a less frequent follow-up in the hospital and in consequence a less frequent absence from school or work. In conclusion, these routinely follow-up visits might put unnecessary burden on both healthcare providers and IBD patients, as well as on healthcare resources. Until now, no clear standard was set for how to organize a remote monitoring programme that is feasible and safe in a large patient population. Despite the possible added value of remote monitoring for IBD patients on stable or no therapy and who are in remission, they are seldomly the targeted population in clinical trials analysing the effects of remote monitoring in IBD. Secondly, a significant reduction in outpatient clinic visits, is often not actively included in the programme, but more an outcome result. Finally, to compose a safe remote monitoring programme, subjective and objective parameters of disease activity should be collected. With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags.

NCT ID: NCT06315179 Not yet recruiting - Ulcerative Colitis Clinical Trials

Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)

STRIDE
Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.