Active clinical trials for "Inflammatory Bowel Diseases"

Background: 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.

Protocol Summary Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory Crohn's disease. Short Title: ExoFlo for Crohn's Disease Phase: 1 Methodology: Open label Study Duration: 24 months Subject Participation: 58 weeks Single or Multi-Site: Multi-Site

The risk of type 2 diabetes appears to be higher in patients with chronic inflammatory diseases, including chronic inflammatory bowel disease (IBD). IBD is a group of inflammatory diseases that includes mainly Crohn's disease and ulcerative colitis. Although the majority of IBD patients are not overweight, the prevalence of obesity in this population remains significant, estimated at 15 to 40%. It has been shown that obesity can impact the response to therapies used in IBD as well as the clinical course of the disease: 1) plasma concentrations of immunomodulatory therapies are often lower in the obese compared to those with a normal Body Mass Index (BMI) with a lower dose per kg of the administered drug as well as an acceleration of drug clearance. 2nd) Surgical management of IBD is associated with a higher risk of peri- and post-operative complications in obese patients, including an increase in operating time, bleeding risk, length of hospital stay and percentage of post-operative infections. 3e) Finally, obesity seems to have a negative impact on the clinical course of IBD, with a correlation between an increase in BMI and an increase in the number of hospitalizations, the number of follow-up consultations and the need for therapeutic escalation. One of the common pathophysiological explanations between IBD and metabolic syndrome (including type 2 diabetes and obesity), would involve metabolites in the gut that are modulated by the gut microbiota. Glucagon-Like Peptide 1 (aGLP1) analogues are a new class of injectable antidiabetic drugs that have revolutionized the management of type 2 diabetes. They include exenatide, lixisenatide, liraglutide, dulaglutide and semaglutide. They combine an effect on glycemic control but also usually a weight loss. In some countries, they are used in non-diabetic obese patients, with a weight loss of up to -10 to -15%. These molecules bind to GLP1 receptors, stimulate insulin secretion when blood glucose levels are high, decrease glucagon secretion, slow gastric emptying and stimulate satiety. In addition to glycemic control, weight reduction is most often associated. In addition, some aGLP1s have been shown to reduce cardiovascular events in diabetics. They are well tolerated, but their side effects are mainly digestive, such as nausea, vomiting and sometimes diarrhea. These problems occur in about 20% of cases, most often after the first injection, with vomiting requiring permanent cessation of treatment. Most often they gradually subside, spontaneously or after symptomatic treatment, and allow titration of the drug. Due to the lack of studies and possible intestinal effects, aGLP1 is not recommended in cases of severe gastrointestinal disease, and therefore in cases of IBD, although it is not contraindicated. The main objective of this study is to test the interest of these GLP1 analogues in type 2 diabetics with IBD, who are overweight and whose glycemic target is not reached. The expected benefit is to facilitate diabetes control and weight loss in this population. The second objective is to monitor the occurrence of adverse events in this population with the different GLP1 analogues used.

There are many limitations in the current treatments of Inflammatory bowel disease(IBD). Some patients have no or little reaction to the traditional drugs. Now the investigators realized that the intestinal microbiota is closely associated with the development of IBD. In recent years, a retrospective study showed that the overall efficiency of fecal microbiota transplantation (FMT) for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators plan to recruit patients with IBD (Ulcerative Colitis and Crohn's Disease) in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with traditional drugs, followed up for at least 1 year. The investigators aim to determine the efficiency, durability and safety of Fecal Microbiota Transplantation for IBD treatment, and further to explore which major microbiota may effect in this project.

The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting effects inflammation in patients with mild to moderate Crohn's disease (CD). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and CD are very limited. Diets that mimick fasting have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide rationale for its use to treat CD.

Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/ l) is associated with irritable bowel disease (IBD). National guidelines recommend the administration of 800 -4000 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly or weekly is possible. The study aims to compare inflammation activity (primary outcome) after monthly or weekly treatment with soft capsules containing 24'000 IU cholecalciferol compared to no vitamin D supplementation. Quantification of 25(OH)-vitamin D serum values is a secondary outcome. The investigators will use newly developed soft capsules.

The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.

To observe the clinical effect of acupuncture on quiescent Crohn's disease

To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity

The investigator is hypothesize that physical activity can have positive effects on health, general well-being , sleep quality and stress in Inflammatory Bowel Disease patients.