Active clinical trials for "Crohn Disease"

Rationale: Crohn's disease (CD) is a chronic, debilitating inflammatory bowel disease (IBD) which is diagnosed during childhood in up to one in ten patients. The use of anti-tumor necrosis factor (TNF)-α agents has significantly ameliorated CD management. Infliximab (IFX) is the first anti-TNF-α agent registered for pediatric CD. The current dosing recommendation of IFX is extrapolated from adult studies, and it is a weight-based dose (5 mg/kg) delivered during induction (infusion at weeks 0, 2, and 6) and maintenance (every 8 weeks). However, pediatric patients have a 25-40% lower drug exposure compared to adults, particularly children under 10 years of age, resulting in diminished efficacy and an increased risk of developing a complicated disease course. The investigators hypothesize that an intensified IFX induction scheme (instead of the current dosing recommendation) is more effective in the treatment of pediatric CD patients. Objective: The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule in improving drug exposure without treatment escalation in pediatric CD patients. Secondary objectives are clinical and biochemical remission without treatment escalation, development of antibodies to IFX (ATI) and adverse reactions. Study design: An international, multicenter, prospective, open-label trial. Study population: Anti-TNF-α naïve children (age 3-15 years) with CD and an indication to start IFX treatment. Intervention: IFX will be given intravenously at 10 mg/kg at week 0, and 5 mg/kg at weeks 2, 4, and 8 to all patients (induction). Maintenance will start at week 12, and then ideally continue every 6 weeks till week 24 (end of study). IFX trough levels will be measured at weeks 4, 12, and 24. During the maintenance, the IFX dose and/or interval adjustments, the IFX discontinuation or the start of a co-medication (i.e., an immunomodulator) will be possible on indication (i.e., primary nonresponse, secondary loss of response, intolerance to study medication) at the physicians' discretion. Follow-up will continue for the duration of the study (week 24). Main endpoint: Proportion of patients with IFX TL ≥ 5 µg/mL at week 12 without treatment escalation.

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.

Study Design: A Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators during Induction treatment in Moderate to Severe Crohn's Disease. Primary endpoint: The proportion of patients in corticosteroid-free clinical remission (as defined by a Crohn's disease activity index (CDAI)<150) and endoscopic response (as defined by a simple endoscopic score for Crohn's disease (SES-CD) drop of at least 50%) at week 26. Accrual and feasibility: This study will enroll 158 subjects at approximately 20 sites in the Netherlands (peripheral and academic hospitals). The estimated enrollment is 0.5 patient/centre/month leading to an inclusion duration of 16 months once all centres are open. The first enrolment is anticipated in Q1 2021. Treatment, dosage and administration: Eligible patients will be randomized to receive SC IFX monotherapy (240mg at week 0 and week 2 and then 120mg every other week (EOW) OR SC IFX (240mg at week 0 and week 2 and then 120mg EOW) in combination with immunosuppression.

Inflammatory bowel disease (IBD) is a chronic illness characterized by inflammation of the intestine. Many individuals with IBD suffer from depressive symptoms and anxiety which can lead to a decreased quality of life, poor treatment compliance, and higher morbidity and mortality. The object of this clinical trial is to investigate the effects of a fasting mimicking diet in IBD patients who are suffering with symptoms of depression. Participants will carry out 3 cycles of a 5-day period of a plant-based low caloric diet or a plant-based caloric sufficient diet following by 3 weeks of eating normally. Effects of the dietary intervention on microbes in the gut, immune and metabolic function, and depressive symptoms will be measured. The overall goal is to develop a safe and effective treatment to improve mental health in patients with IBD by targeting the gut microbiome through dietary interventions.

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures To evaluate the safety and tolerability of the 2 different dose regimens To evaluate the immunogenicity of the 2 different dose regimens The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

A phase II, national, multicenter, uncontrolled and open trial to evaluate the feasibility and safety of laparoscopic administration of adipose derived allogenic mesenchymals stem cells (adMSC), for the treatment of patients with a single inflammatory stenosis in the context of Crohn's disease.

This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks. There will be up to 20 study visits over 58 weeks to complete assessments.

This is a Phase IIa (proof of concept), single center clinical trial to evaluate the safety and efficacy of daily MBF-118 oral treatment during 28 days in Crohn's disease patients on top of standard of care.

Paediatric and adolescent patients with chronic pain associated with their medical condition will be invited to participate in this study. Most patients for this study will be recruited from gastroenterology and hepatology clinics at KCH. Therefore the rationale for the study is primarily with consideration of each of these medical conditions all with the common symptom of chronic pain. Inflammatory bowel disease disorders(IBD), such as Crohn's Disease and Ulcerative Colitis, disorders of gut-brain interaction (DGBI) all experience chronic pain. however children with DGBI do not have an underlying specific lesion causing the pain. The chronic pain is the disease. In addition to this Chronic pancreatitis in children and adolescents can cause severe pain. All of these groups of patients suffer with chronic pain and this can result in failure to thrive and have a negative impact on quality of life. There is a need for further development of a non - pharmacological approach to support these patients with their symptoms of pain and in turn improve quality of life. This study is designed to evaluate the benefits of a complementary natural therapy for paediatric and adolescent patients registered at King's College Hospital, with a diagnosis of a disease or disorder with associated symptoms of chronic pain. The age group is 5-18 years old. The therapy to be evaluated is an energy therapy (Pranic Healing). This therapy is non -invasive, non- touch, non- pharmacological and natural. The study will assess the benefits these patients experience with their symptoms of pain after 8 weeks of weekly energy therapy sessions each session is 30 minutes and 3 visits each 4 weeks apart. Qualitative and Quantitative data will be collected and evaluated.

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.