Digital Behavioral Interventions in Inflammatory Bowel Disease
Crohn DiseaseUlcerative Colitis5 moreGiven the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.
Panaceo "MED" for IBS (Irritable Bowel Syndrome)
Irritable Bowel SyndromeMicrobial Colonization1 moreZeolite clinoptilolite is a volcanic mineral from the group of zeolites. The porous structure is associated with a large inner surface. Due to the anionic framework charge, ions (e.g., Pb^2+) can be absorbed or exchanged. The specific Panaceo PMA zeolite is approved as a class IIa medical device for the repair of the intestine inner lining. It is CE certified and complies with the relevant European Union regulations in terms of safety and effectiveness. Zeolite is known for its absorbing properties. Because of these properties and the results of several human studies, it warrants the investigation of possible effects on specific indications in human medicine, e.g. irritable bowel syndrome. The diagnosis "irritable bowel syndrome (IBS)" is according to the ROME Foundation, an US medical society. IBS is a disorder with dysfunction of the bowels, a latent inflammation is discussed. The present study aims to evaluate the following effects in patients with IBS: Primary endpoint: effect on the symptoms of IBS. Secondary endpoint: intestinal wall permeability, integrity of the tight junctions as measured by the change in zonulin concentration in the stool. Further endpoints: Inflammation parameters and anti-inflammatory laboratory parameters. Biodiversity of the gastrointestinal microbiome. histamine-associated parameters. Constipation as a possible side effect. For this purpose, a double-blind randomized controlled trial (RCT) is realized prospectively in a monocentric outpatient-controlled study. The subjects take the test compound daily (verum, reference substance) for 12 weeks and document the intake of the study-substance, intake of medications, stool-frequency and consistency. They receive "before" and "after" the intervention phase a blood and stool analysis for the determination of parameters for intestinal wall integrity (zonulin) inflammation (hsCRP, interleukin-10, calprotectin), histamine metabolism, microbiome diversity. The pilot study is realized ahead of the detailed planning of a later main study.
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
Pelvic Organ ProlapseUrinary Incontinence,Stress4 moreThis study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence. Half of the participants will undergo Burch colposuspension procedure at the time of sacrocolpopexy, and half of the participants will undergo sacrocolpopexy alone.
LIFEwithIBD: Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease
Inflammatory Bowel DiseasesThis investigation aims to apply and test the feasibility of an acceptance, mindfulness and compassionate-based intervention structured for inflammatory bowel disease patients. LIFEwithIBD programme for inflammatory bowel disease thus comprises 9 weekly group sessions, lasting 1 and a half hour each, run in small groups at a Gastroenterology Service at the Coimbra's University Hospital. For each week participants have assigned homework (e.g., mindfulness exercises). The efficacy of LIFE-IBD Group Intervention to improve quality of life, mental health, and disease activity-related scores will be tested in a sample of Portuguese patients. Additionally, this study expected that the observable changes after the intervention completion will be attributed to changes in emotional regulation processes and maintained over the follow-up periods.
iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
Inflammatory Bowel DiseasesThe iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer program and those in the control group (no mentor).
Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)
Irritable Bowel SyndromeDigestive System Diseases3 moreThe purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto [TU-100] is a botanical agent that modulates gastrointestinal nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation threshold for pain) in response to rectal balloon distension by barostat in patients with IBS.
Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot...
Quality of Life in Patients With Inflammatory Bowel DiseasePatients with inflammatory bowel disease (IBD) suffer from a diminished quality of life compared to healthy adults. This is due to the chronic course of disease accompanied with diarrhea, stomach pains but also with psychological stress. It is known that physical education may improve course of disease and quality of life in a multitude of diseases. These include coronary heart disease, malignancies and also depression. The investigators believe that sport is as effective supportive tool in improving quality of life in IBD patients. But data is lacking with regard to controlled randomized clinical trials. Because of the small amount of data available the investigators considered a feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The investigators further suspect that these patients improve their quality of life compared with patients in the control group.
Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel...
Inflammatory Bowel DiseasesIn this trial, investigators will infuse donor bone marrow mesenchymal stromal cells intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has not responded to conventional therapies. The goals of this study are to test the safety and tolerability of donor mesenchymal stromal cells in children with Inflammatory Bowel Disease. Mesenchymal stromal cells support the development of blood cells within the bone marrow. When isolated from a donor and infused into an animal or human, they have been demonstrated to travel to areas of inflammation, to alter immune responses, to decrease pro-inflammatory cytokines, and to promote tissue repair. Infusion of these cells does not lead to rejection. These properties lead investigators to hypothesize that that these may be they may be beneficial in treating inflammatory bowel disease.
Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease
Intestinal DiseasesUlcerative Colitis1 moreBioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy of mangoes has not previously been compared with respect to mild inflammatory bowel disease. In order to justify future pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step. Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would have a significant impact on public health.
Low Volume Colon Preparation for IBD
Inflammatory Bowel DiseaseComparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.