Treg Immunotherapy in Crohn's Disease
Crohn DiseaseCrohn's Disease (CD) is a condition that causes inflammation of the digestive system or gut. Crohn's can affect any part of the gut, though the most common area affected is the end of the ileum (the last part of the small intestine), or the colon. Crohn's is a chronic condition. This means that it is ongoing and life-long, although patients may have periods of good health (remission), as well as times when symptoms are more active (relapses or flare-ups). Current available therapies frequently fail to maintain long-term remission and may be complicated by significant side effects. There is an unmet medical need for novel therapies. Cellular therapies are emerging as potentially attractive therapeutic strategies. The TRIBUTE trial will use autologous regulatory T cells (Tregs) expanded in vitro. It is hoped that the administration of this treatment to patients with active CD will change the immune responses in the gut and reduce bowel wall inflammation.
Vegetarian Diet in IBD
Ulcerative ColitisCrohn Disease1 moreTo determine whether a lacto-ovo vegetarian diet is effective in improving gastrointestinal symptoms, quality-of-life, intestinal inflammation and gut microbiota composition in mild-to-moderate IBD compared to a standard omnivorous diet.
MSC Intratissular Injection in Crohn Disease Patients
Efficacy and SafetyThe main objective is to assess the efficacy of local injection of MSC on the healing of refractory intestinal and perianal lesions in crohn disease. The second co-primary endpoint is safety.
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable...
Autoimmune DiseaseCrohn Disease12 moreThis phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel...
Inflammatory Bowel DiseasesCrohn Disease1 moreProspective, multicentre trial which the biologic treatment will be initiated by clinical indication. The treatment selection anti-TNFα (infliximab, adalimumab or golimumab), vedolizumab and ustekinumab will be made at the discretion of the clinician. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.
Loss of RESponse to Ustekinumab Treated by Dose Escalation
Crohn DiseaseThe aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn's disease who show a secondary loss of response over time
Pediatric MSC-AFP Sub-study for Crohn's Fistula
Fistula in AnoCrohn DiseaseThe purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the patient.
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in...
Crohn's DiseaseThis research is a multicenter French randomized and single blinded phase III clinical trial evaluating two treatment strategies among Crohn's disease (CD) patients. The main objective is to assess if the addition of Crohn's Disease Exclusion Diet (CDED) to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED
Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study
Crohn DiseaseTo assess the safety and efficacy of transcutaneous vagal stimulation in adult patients with active Crohn's disease.
Empagliflozin as a Treatment for Severe Congenital Neutropenia Due to G6PC3 Deficiency
Crohn's DiseaseGlycogen Metabolism1 moreBackground: Severe congenital neutropenia (SCN) is an immune system disease. People with SCN do not have enough of a kind of white blood cell called neutrophils. This means they get sick easily from infections. Some drugs to treat SCN have lots of side effects. Researchers want to see if a the drug empagliflozin can help increase the number of neutrophils in a person with SCN. Objective: To see if a drug called empagliflozin can help people with SCN. Eligibility: Adults aged 18 and older with SCN. Design: Participants will be screened with a physical exam, medical history, and blood tests. They may have a pregnancy test. Participants will have study visits and local lab visits. They will repeat the screening tests. They will have heart and lung function tests. They will have an ultrasound of the liver and spleen. Their skin symptoms will be photographed. They may have consultations with specialists. They may give a stool sample. They may have an optional colonoscopy with tissue sample collection. They may have an optional bone marrow biopsy and aspirate. They may have an optional magnetic resonance imaging scan of their heart. Participants will be admitted to NIH for 5 7 days. They will start taking the study drug as a pill once daily. They will be monitored for side effects. Participants will take the study drug at home for 12 months. They will use a fingerstick blood glucose meter to measure blood sugar at home. Participants may be able to take the study drug through their local doctor after the study ends. Participation will last for 15 months.