Active clinical trials for "Inflammatory Bowel Diseases"

Background Psoriasis is a common disease which is a source of major distress for patients and costs for the society. Treatments are effective but temporary and relapses occur, preferentially at sites previously involved. Locally, tissue resident memory T cells (TRM) cells prone to produce pathogenic cytokines accumulate in the outer layers of the resolved skin of psoriasis patients under treatment, and can trigger strong inflammatory responses upon reactivation, thus starting the cascade of the relapse. We have recently shown that the skin transcriptional responses after TRM cell activation in healed skin biopsies of patients could predict the time until the disease relapse. How to modify the local pool of TRM cells in the human skin is not known, but several factors leading to the establishment and the persistence of the TRM cells in the skin are suggested. First, the skin microbiota has emerged as a potent actor of the skin immunity, with the capacity to shape the pool of skin T cells in mice. Second, after TRM cells are settled in the skin, their lipid intake will impact their local survival. Last, in addition to these local factors, the gut subclinical inflammation that lead to bacterial translocation can trigger a more global state of inflammation in the body and could drive the local survival of the TRM cells in the skin. Aims Our first aim in this project is to validate a tool to predict psoriasis relapse upon treatment withdrawal in a cohort of patients treated with systemic drugs- the STOPso cohort (Shortening Treatments Of Psoriasis). We will correlate the skin reaction to local TRM activation in resolved lesions to the time before relapse. In parallel, we will characterize several factors likely to participate to the establishment, function and survival of the TRM cells in the skin. We will decipher the skin microbiota and mycobiota; the lipid composition of the outer layer of the skin; the presence of lipopolysaccharide in the blood, in order to better understand what factors should be targeted to modify the skin populations of TRM cells. Methods Patients will be recruited through the Dermatology department of the university hospital of Besançon. We will use skin biopsies from resolved lesions to perform the characterization of the skin responses at the transcriptional level after local TRM activation with OKT-3 antibody compared to control. RNA will be analyzed with Nanostring technologies. For the microbiota analysis, we will use wet swabs and later DNA sequencing. The lipid composition and the circulating LPS will be analyzed after tape stripping, through the LabEx LipSTIC lipidomic platform of the region Bourgogne Franche-Comté. Patients will be followed up at Month 1, Month 6, Month 12 and Month 18 and at time of relapse if it occurs in between those intervals. Data about the disease activity (PASI, quality of life scores) and inter-current events will be registered at each time point. Expected results and Perspectives The final aim of this project is to validate a tool available to clinicians to guide them in their decision to withdraw an efficient treatment in psoriasis, based on the skin reactivity to the resident T cells left locally after resolution of the inflammation. This would help reduce treatment length, and thus toxicities and costs to the health care systems. To open future perspectives, we also want to better understand the reasons why TRM populations tend to be retained in the skin, in order to develop remodeling strategies of the skin TRM populations.

The goal of this mixed-methods prospective cohort study is to assess the impact of shared decision-making (SDM) on newly diagnosed pediatric inflammatory bowel disease (IBD) patients and their families. Patient and familial decisional conflict regarding the choice and course of treatment is shown to be high, especially for the newer class of IBD treatments called biologic agents. SDM intervention comprises of coaching with a decision coach (DC) on all aspects of treatment and care, along with educational decision aids (DA) provided and adapted from Cincinnati Children's Hospital Medical Center. The main aims of this study are: to determine if SDM intervention has an impact on patient and parental decision making in pediatric IBD treatments, mainly by assessing decisional conflict and decision satisfaction/regret. to adapt and assess the acceptability of DA in a Canadian academic center. Participants who have been recommended a new biologic as part of their clinical care for IBD will be recruited to the SDM intervention group. The participants will have DC sessions until a final treatment decision is made, will be given DAs, and will be followed by baseline and post-intervention surveys to assess decisional conflict and satisfaction/regret. The comparator group will include participants who have been recommended and have commenced a new biologic within the last 12 months. Outcome metrics will evaluate the impact on parental and patient decisional conflict following SDM intervention, and decisional satisfaction/regret 6-12 months from therapy start.

Inflammatory Bowel Diseases (IBD) go through two phases: flare and remission. Prediction of flares and identification of patients in remission but at high risk of flare are a major issue when taking care of IBD patients. Considering close interactions between sleep, immunity and intestinal inflammation, sleep disorders could be a predictor of flares. The purpose of this study is to demonstrate that sleep efficacy decreases before IBD flare. Patients in remission will be assessed for IBD symptoms (activity scores, biological factors) and sleep disorders (actigraphy, DREEM®, questionnaires) during one year.

This study is the first administration of GSK2983559, a selective receptor interacting protein 2 (RIP2) kinase inhibitor, to humans. This will be randomized, double-blinded (sponsor open) and two part study (A and B). Part A of the study is single ascending dose crossover design with two separate cohorts (1 and 2). In Part A, 9 single dose levels will be explored. In Cohort 1, 10 healthy subjects will randomized to receive single oral doses of either GSK2983559 or placebo in a ratio of 4:1 in 5 way cross-over design with 5 treatment periods. In Cohort 2, 8 healthy subjects will be randomized to receive single oral doses of either GSK2983559 or placebo in a ratio of 3:1 in 4 way cross-overs design with 4 treatment periods. In Cohort 2 there will be an additional period (period 5-open label) for assessing GSK2983559 under fed conditions. There will be 48 hours wash-out period between each dose escalation period. Part B is repeat ascending dose sequential group design. It will contain 4 Cohorts of and dosing will be done sequential dosing. Subjects in Part B will receive once daily (QD) dose or twice daily dose (will be decided based upon the pharmacokinetic, safety and tolerability observed in Part A). There will 58 subjects involved in this study. Total duration of Part A will be approximately for 11 Weeks and Part B will be approximately for 15 Weeks.

Very early onset inflammatory bowel disease (VEO-IBD) is a special subtype of children's inflammatory bowel disease (IBD). VEO-IBD is mostly caused by single-gene defects and can be cured by allo-hematopoietic stem cell transplantation ( HSCT). Umbilical Cord Blood Transplantation (UCBT) is less reported in these patients.

Patients with the chronic bowel disease pouchitis is disabled by bloody diarrhoea and abdominal pain often followed by fever. Pouchitis is an inflammation in a pouch, a reservoir formed by the small intestine in the management of the chronic inflammatory bowel disease, ulcerative colitis. Chronic pouchitis is a rare disease with a prevalence in Denmark of <1.8 per 10,000 people, mostly younger people (<50 years). The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Recent studies show that patients with pouchitis have an altered composition of the gut flora, called microbiota, compared to healthy individuals. As shown by several studies, faecal microbiota transplantation (FMT) with administration of faeces from healthy donors can alter the microbiota. Treatment with faecal microbiota transplantation is today known to be the ultimate treatment for antibiotic resistant recurrent bowel infection with the bacteria Clostridium difficile. It is however still uncertain if faecal microbiota transplantation can be used to the treatment of chronic pouchitis. The study primary aims to investigate if transplantation of faeces from healthy donors administrated as enemas to patients with chronic pouchitis is superior to placebo for the treatment of pouchitis. The project is designed as a multi-center, double-blinded, randomized, placebo-controlled treatment study. A positive result from the project will result in an improved treatment to pouchitis patients. Moreover, repeated long-lasting broad-spectrum treatments with antibiotic, which carry a high risk of antibiotic resistance in the society, will be avoided.

This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.

The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.

Transcranial magnetic stimulation (rTMS) has demonstrated diagnostic and therapeutic potential for a number of conditions and is an approved treatment for depression. Inflammatory Bowel Disease (IBD) has a significant impact on mental health, and comorbid maladaptive behaviors and pain are highly prevalent in patients with IBD and are often under-treated. The investigators predict TMS will improve comorbid maladaptive behavior (heightened interoceptive awareness, sleep, fatigue, catastrophizing, anxiety and depression), reduce pain and improve quality of life in persons with inflammatory bowel disease (IBD). Further, TMS benefits will be associated with changes in gut microbiome as measured by stool, blood and urine samples and normalization of IBD-associated changes in brain structure and/or function as measured by magnetic resonance imaging (MRI).

This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. The purpose of this study is to determine if the IBD patients doing home monitoring (screening themselves on demand (OD) or every 3 months) have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD patients are self-monitoring by web apps consisting of a short disease activity questionnaire (DA) and fecal calprotectin (FC) on any smart phone.