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Intestinal Diseases clinical trials

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NCT ID: NCT03833999 Completed - Ondansetron Clinical Trials

Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea

MOLID
Start date: October 16, 2018
Phase: Phase 4
Study type: Interventional

This is a double-blind, two period, two treatment crossover trial of ondansetron verses placebo studying the effects of ondansetron in the small and large bowel, specifically its effects on the amount of water in the gut, measured by MRI.

NCT ID: NCT03833778 Completed - Clinical trials for Chronic Inflammatory Intestinal Diseases (CED)

Kids + Adolescents Research Learning On Tablet Teaching Aachen

KARLOTTA
Start date: February 5, 2019
Phase: N/A
Study type: Interventional

The aim of this study plan is to implement a tablet quiz in the German-speaking area, in order to test the specific knowledge about chronic inflammatory intestinal diseases (CED) concerning pediatric patients in the context of an age-appropriated and interesting digital playing environment, and to process knowledge gaps at the subsequent doctor's contact. The quiz should be combined with a game and can be performed by the patients, while they wait in the ambulance for their doctor's appointment. The investigator's goals are to grasp playfully gaps in the CED knowledge regarding the patients and to use these in the following consulting hour for clarification and advice in line with a better understanding of the disease. With this, the specific knowledge, the understanding of the disease, the therapeutic adherence, and the self-efficacy should improve the self-responsible handling of the disease. In particular, the willingness of the group of older teenagers to transit into the adult medicine can be collected and processed. The investigators want to check the efficacy in a randomized, controlled study with two groups of 15 pediatric CED patients. The hypothesis is that the additional play of the tablet-CED-quiz and the individualized advice have a positive impact on the CED knowledge, the disease activity, the CED-related life quality and the willingness of teenagers for transition.

NCT ID: NCT03831750 Completed - Clinical trials for Inflammatory Bowel Diseases

Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)

Start date: February 22, 2019
Phase: N/A
Study type: Interventional

The investigators have designed a guided, online, tri-component, stress reduction intervention for participants with inflammatory bowel diseases.

NCT ID: NCT03817645 Completed - Clinical trials for Irritable Bowel Syndrome

Panaceo "MED" for IBS (Irritable Bowel Syndrome)

PCeo-17
Start date: March 9, 2018
Phase: N/A
Study type: Interventional

Zeolite 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.

NCT ID: NCT03801928 Completed - Clinical trials for Ulcerative Colitis (UC)

Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease

ONWARD
Start date: February 23, 2018
Phase:
Study type: Observational

This is a prospective, observational, multicenter study conducted in adult patients with ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in the United States and Canada in which the participating physician has decided to treat with INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after the decision to initiate treatment with INFLECTRA.

NCT ID: NCT03799471 Completed - Chronic Pain Clinical Trials

Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease

Start date: February 26, 2019
Phase:
Study type: Observational

This study evaluates nervous system hypersensitivity in individuals with inflammatory bowel disease (IBD) and experiences of ongoing musculoskeletal (MSK) pain. Previous results and current literature suggest that MSK pain in IBD may be influenced by hypersensitivity of the central nervous system, termed central sensitization. However, specific mechanisms contributing to pain experiences are unknown. Therefore, primary aims are to explore aspects of central sensitization through sensory testing in this population, and to investigate association of psychological and IBD features to sensory profiles. This study hypothesizes that IBD patients with MSK pain will demonstrate altered sensory function, and IBD/psychosocial features will be associated with altered sensory functioning and worse pain experiences.

NCT ID: NCT03779256 Completed - Quality of Life Clinical Trials

Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life

ENDO
Start date: December 10, 2018
Phase:
Study type: Observational

Endometriosis on the bowel is a benign condition that can cause major complaints and severely affect the quality of life of women of fertile age. If medical treatment is not enough to improve pain and/or other symptoms it may be necessary to undergo major surgical treatment and removal of the endometriosis nodule on the bowel. Such extensive surgical treatment carries risks of serious complications. Therefore, a thorough diagnostic work-up before surgery is important to know the extent of disease. This will provide women with the best possible information and for the surgeon to plan the operation. The risk of complications increases as the bowel endometriosis is localized closer to the anus as well and/or if the bowel nodule is large. The distance between the anus and the nodule and the size of the nodule can be measured with two dimensional (2D) vaginal ultrasound. Additionally, Magnetic resonance imaging (MRI) is also used in some countries for these same measurements. Our study would like to investigate the diagnostic value of 2D ultrasound and MRI as well as learn more about women's quality of life before and after surgery. The investigators have designed the study to evaluate the following three questions into three studies ENDO1, ENDO2 and ENDO3: - ENDO1: How good is 2D transvaginal ultrasound at measuring the size of the bowel endometriosis nodule and the distance between anus and the lower part of the bowel nodule compared to measurements done during surgery? - ENDO2: What is the quality of life, sexual and bowel function of women before and 3- and 12-months after surgery due to bowel endometriosis? Questionnaires will be used. - ENDO3: How good is 2D transvaginal ultrasound at measuring the size of the bowel endometriosis nodule compared to magnetic resonance imaging (MRI) and measurements done during surgery?

NCT ID: NCT03761147 Completed - Bowel Dysfunction Clinical Trials

Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Women generally report discomfort and a delay in GI motility after CS. The Paula method, circular exercises of ring muscles has been shown to increase GI motility. This method had not been studied in women post CS. The current study is comparing the resumption of bowel sounds after CS in women utilizing the Paula exercises to standard care (no exercises).

NCT ID: NCT03757533 Completed - Clinical trials for Inflammatory Bowel Diseases

Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease

Start date: June 11, 2019
Phase: N/A
Study type: Interventional

Inflammatory bowel disease (IBD) including Crohn's disease (CD) and Ulcerative colitis (UC) is a chronic idiopathic intestinal disorder involving the interplay of environmental, immunomodulatory and genetic causative factors. Treatment for IBD is multimodal and includes lifestyle modification, chronic pharmacotherapy and surgery. Given the need for chronic pharmacotherapy, medication adherence is a crucial therapeutic goal in the management of IBD. In fact, medication non-adherence has been associated with greater risk of relapse and increased healthcare costs. In a previous study, the investigators found clinically identifiable risk factors for non-adherence for self-injectable biologic medications in a population with moderate to severe CD. These risk factors included smoking, prior biologic use, psychiatric history, and current narcotic use. The primary objective of this study is to use a multidisciplinary team approach that implements a targeted coaching intervention to promote behavioral change and improve medication adherence in adult patients with IBD who are at high risk of non-adherence.

NCT ID: NCT03753425 Completed - Clinical trials for Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease

National Multicentric Observatory of Low Bowel Preparations in Patients With IBD

CLEAN
Start date: March 2, 2017
Phase:
Study type: Observational

National multicentric observatory of low bowel preparations in patients with IBD