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Inflammatory Bowel Diseases clinical trials

View clinical trials related to Inflammatory Bowel Diseases.

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NCT ID: NCT06392061 Recruiting - Quality of Life Clinical Trials

Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease

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

The study is a single-center, randomized, single-blinded, controlled trial conducted at ZHUMC's endoscopy unit. It aims to assess the short-term effects of probiotic administration on disease course, quality of life, and nutritional status among patients diagnosed with inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) and Crohn's disease (CD). Patients with UC and CD will be recruited from the endoscopy unit's outpatients and divided into two groups: a control group and an intervention probiotic group. The intervention probiotic group will receive the probiotic intervention for 2 months. During the study period, two visits will be scheduled for all patients. At each visit, medical and nutrition surveys will be filled out, and body composition measurements will be conducted. These assessments will help evaluate the impact of probiotic administration on the participants' disease progression, their quality of life, and their nutritional status. Overall, the study aims to provide insights into the potential benefits of probiotic supplementation in managing IBD and improving the well-being of patients with these conditions.

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: 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: NCT06353633 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.

NCT ID: NCT06351124 Recruiting - Crohn's Disease Clinical Trials

Beta-Hydroxybutyrate Feasibility Treating IBD

BHB
Start date: May 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease. The main questions it aims to answer are: - BHB supplementation will be feasible and acceptable to patients. - BHB supplementation will be associated with a reduction in systemic inflammation. - BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies. Participants will: - Take 3 capsules x 3 times per day for 4 weeks. - Document food consumption using a 24-hour food recall questionnaire. - Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark. Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease.

NCT ID: NCT06346288 Recruiting - Clinical trials for Inflammatory Bowel Disease

A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease

Start date: May 6, 2024
Phase: Phase 4
Study type: Interventional

Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States. Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months. Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects.

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: NCT06321887 Recruiting - Clinical trials for Inflammatory Bowel Disease

EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD

CAESAR
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD.

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.