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NCT07089771
People with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease affecting the colon, have a higher risk of developing colon cancer over time. To catch early signs of cancer, regular colonoscopies are recommended. In this study, the investigators are comparing two advanced methods of examining the colon during these surveillance colonoscopies. One method uses a special dye sprayed inside the colon to highlight abnormal areas (called dye-based chromoendoscopy). The other method uses new technology built into the camera to enhance the view without needing any dye (called virtual chromoendoscopy). Both methods use modern, high-definition equipment. The purpose of this study is to find out if the newer, dye-free method is as good as the traditional dye method at detecting pre-cancerous changes (called dysplasia) in people with IBD. Adults with IBD who are due for a routine surveillance colonoscopy may be invited to take part. Participants will be randomly assigned to one of the two methods. No additional procedures are involved, and only the way the colon is viewed differs. The investigators will also look at how long the procedures take, how many biopsies are needed, any complications, and how patients experience the exam. Participants will be followed over time using national health records to check for long-term outcomes. This research will help doctors better understand which method is most effective and comfortable for patients, and may guide future recommendations for cancer screening in people with IBD.
NCT07433946
This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers. IBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk. Participants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal/day) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA/BIVA, vitamin B12/D, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score). The study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.
NCT07243639
Eligible patients will be identified in regular clinical practice. After providing thorough explanation and obtaining voluntary written informed consent, the clinical course, adverse events, endoscopic findings, and histopathological changes in biopsy specimens after Etrasimod administration will be prospectively collected and analyzed.
NCT07115862
The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will: 1. lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life 2. affect the microbes living in the gut (gut microbiota)
NCT07167186
Inflammatory bowel diseases (IBD) are long-term conditions affecting more than 250,000 people in France. They typically begin in young adults and are characterized by flare-ups interspersed with periods of remission. The impact of these diseases goes beyond digestive symptoms, with fatigue present in 50 to 80% of cases. The overall effect on health leads to a decline in quality of life and work productivity. Therapeutic management relies on long-term immunosuppressive treatments aimed at inducing prolonged remission. While therapeutic management has become more complex with an increasing number of available treatments, evaluating the effectiveness and tolerance of these treatments requires a multimodal approach, including therapeutic education and specific follow-up based on the patient's profile and treatment, with the goal of comprehensive care and precision medicine. Recently, multimodal day hospitalizations have been developed, particularly in response to the recent evolution of treatment administration routes toward subcutaneous or oral forms. In 2022, the gastroenterology and nutrition department of Saint Antoine Hospital, which follows 3,500 patients with CIBD, created a multimodal day hospital (DH) (four interventions) dedicated to patients treated with biologics and Janus kinase inhibitors. In a single session, this approach systematically combines (1) specific biological tests, especially pharmacokinetics, (2) a consultation with a gastroenterologist, (3) a consultation with a therapeutic education nurse, (4) and, depending on the identified needs of the patients, a dietary workshop or fatigue management session; a specialized dermatology or rheumatology consultation; and an ultrasound of the intestinal wall. The goal of this study is to assess the benefits of a multimodal day hospital on the management and skills of patients with IBD.
NCT05119140
The objective of this study is to assess the efficacy of hydroxychloroquine (HCQ) when combined with Mesalamine in reducing clinical and histologic disease activity in patients who have active mild to severe Ulcerative Colitis (UC) and also to assess the immunological effects of hydroxychloroquine in this population. These outcomes will be evaluated both clinically and experimentally. In vitro, flow cytometry will be employed to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with HCQ, and then at the end of a 4 month follow up period. Suppression assays will be used to determine the functional capacity of the patient derived Tregs. Clinically, patients will be monitored for remission as defined by reduction in patient reported stool frequency and rectal bleeding (mayo sub-score 0 or 1) and endoscopically, by improvement in mucosal appearance (mayo sub-score 0 or 1), all objective measures in the mayo score.
NCT06691061
The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.