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Intestinal Diseases clinical trials

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NCT ID: NCT06178302 Not yet recruiting - Heart Failure Clinical Trials

DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice

EMANCIPATE
Start date: January 2024
Phase:
Study type: Observational [Patient Registry]

Background: Clinical trials often include patients from large hospitals or university clinics. Information on patients cared for at offices from statutory health insurance-accredited physicians represent evidence gaps. Aims/Objectives: The present study has three aims: First, to systematically describe the patient population of a large group practice for internal medicine. Second, to identify high-risk patients using established risk scores. And third, to include routine imaging data to optimize patient management. Methods/Facility Enrolling Participants: This is a prospective, observational study assessing patients' baseline characteristics, risk evaluation and integrating data from imaging test. The setting of the present study is a large group practice for internal medicine which consists of statutory health insurance-accredited physicians. Study participants will be included during daily routine, real-world clinical care and therefore represent all-comers fulfilling the inclusion criteria: 1. Female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (TSH) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules. 2. Routine laboratory results available within the last 3 months. 3. Available imaging data within the last 3 months performed on site. Perspective: The study is designed to evaluate the current situation and quality of health care in defined patient populations in the routine clinical setting of a large-scale public office. These data will provide a profound rationale to identify quality issues and limitations in our performance of guideline-conform treatment in routine patient care.

NCT ID: NCT06165029 Recruiting - Clinical trials for Inflammatory Bowel Diseases

IUS Combined With VAT Predicts Anti-TNF-α Efficacy in Patients With IBD: a Prospective Study

Start date: November 22, 2023
Phase:
Study type: Observational

Inflammatory Bowel Disease (IBD) is a chronic recurrent nonspecific inflammatory disease of the intestinal tract that can involve multiple organs and systems, mainly including Crohn's disease (CD) and ulcerative colitis (UC). Recurrent disease episodes lead to high rates of disability and unemployment, resulting in a heavy social and economic burden. Currently, the main therapeutic agents for IBD include aminosalicylic acid preparations, glucocorticoids, immunosuppressive agents, and biologic agents, e.g. tumor necrosis factor-a (TNF-a) inhibitors, ustekinumab, etc., with TNF-a inhibitors being the most commonly used in IBD. The latest guidelines and expert consensus on the diagnosis and management of IBD clearly recommend the use of anti-TNF-a agents. However, not all patients are satisfied with the efficacy of anti-TNF-a agents, and studies have shown that up to 33.7% of responders to induction therapy experience secondary loss of response within a year of starting treatment. Patients remain at risk of poor efficacy or treatment failure with these drugs. Therefore, effective prediction of drug efficacy in patients with IBD is an urgent clinical problem, and the discovery of highly sensitive and specific assays that can identify patients most likely to benefit from treatment as well as those most likely to experience a loss of response is important for guiding clinical therapeutic strategies. Currently, there are no relevant studies at home or abroad on the combination of intestinal ultrasound (IUS) with visceral adipose tissue (VAT) to predict the response to anti-TNF-a therapy in IBD patients. Therefore, the investigators propose for the first time that IUS combined with VAT is used as a method to predict the efficacy of anti-TNF-a therapy in IBD patients and to further guide the development of individualized treatment plans.

NCT ID: NCT06162936 Recruiting - Clinical trials for Chronic Granulomatous Disease

Neutrophil Oxidative Burst in Early and Late Onset Pediatric Inflammatory Bowel Disease

Start date: November 1, 2023
Phase:
Study type: Observational

ABSTRACT Introduction Residual or absent oxidase function in peripheral neutrophils may point to an inborn defect of neutrophil function - chronic granulomatous disease (CGD) - whereas low to normal oxidative burst capacity has been linked to variants in various members of the NADPH-complex. Aims To assess the clinical value of routinely measuring oxidative burst activity of granulocytes in pediatric patients diagnosed with very early onset IBD (VEO-IBD) and late onset IBD. Objectives To investigate possible correlations between neutrophil function and IBD disease activity and to inquire the presence of genetic variants in those with low to absent oxidative burst. To identify the rate of monogenic VEO-IBD in our cohort. Materials and Methods The proposal constitutes a collaborative effort among Romanian pediatric tertiary care centers to examine the value of assessing neutrophil function in all pediatric IBD patients. Children aged <18 years diagnosed with Crohn's disease, ulcerative colitis or IBD-undetermined and age-matched healthy controls are recruited. A DHR flow cytometry assay is performed in included subjects and controls. Reduced or absent burst activity will lead to genetic testing in search of overt immunodeficiency or susceptibility variants. All VEO-IBD patients will have an immunological work-up in search of a primary immunodeficiency. Expected Results We anticipate to include a number of 150 pediatric patients with IBD over 12 months from the three pediatric gastroenterology units in Bucharest, Romania. We expect to identify an overall diminished neutrophil function in IBD patients versus controls and possible variants in the NADPH-complex genes.

NCT ID: NCT06157034 Completed - Clinical trials for Pulmonary Tuberculosis

Prokinetic Effect of Selected Nutraceuticals

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural medicines help in alleviating gastrointestinal disturbances. This study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.

NCT ID: NCT06124833 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Integrated Gut Microbiome Data in Inflammatory Bowel Disease

Start date: October 4, 2023
Phase:
Study type: Observational [Patient Registry]

The inflammatory bowel disease (IBD) is a condition that afflects approximately 5 million people worldwide, with 1.4 million in the US and 2.2 million in Europe. By 2030, it is predicted that up to 1% of the entire Western population will have this disease. Notably, IBD encompasses conditions like Crohn's disease (CD) and Ulcerative colitis (UC). The emergence of this disease in non-Western countries is attributed to the rapid urbanization and industrialization which has led to the adoption of Westernized diets, an increase in the use of antibiotics early in life, and air pollution. These factors are suspected to induce changes in the gut microbiome, contributing to the rise of IBD. However, as an immune-mediated chronic intestinal disease, it is a multifactorial condition triggered by genetic mutations, gut microbial features, and environmental factors. Despite numerous studies, the exact causes remain insufficiently understood, emphasizing the importance of research and development to significantly benefit the health of the rapidly increasing patients. The study aims to construct a multi-omics analysis platform, including gut microbiome analysis, using biosamples collected from Korean patients with inflammatory bowel disease (IBD) and their families. Through this platform, comparative clinical research will be conducted to elucidate the pathophysiology of the disease and develop potential biomarkers.

NCT ID: NCT06123052 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

A Qualitative Study on Patients' (un)Ability and (un)Willingness to Use Telemonitoring in Inflammatory Bowel Diseases

Start date: February 2024
Phase:
Study type: Observational

Introduction: Telemedicine has shown to play a promising role in improving IBD treatment. However, it remains uncertain which patients benefit from telemedicine. A feasibility and development project using IBD Care Everywhere (IBD-CE), a telemonitoring application, found that some patients were unable or unwilling to use the application. However, why patients were not able or willing to use the application remains unknown. The WHO global strategy aims to implement telemedicine while ensuring digital health equity. Concerns exist that telemedicine may exacerbate healthcare disparities. Research question: The aim of this qualitative study is to get a better understanding of factors influencing patients' (un)ability and (un)willingness to use IBD-CE. These insights could help to offer the best individualised IBD care to patients. This led to the following research questions: 1. What influences patients' (un)ability or (un)willingness to use IBD Care Everywhere? 1.1 What are the distinguishing characteristics of patients (un)willing and (un)able to use IBD Care Everywhere? 1.2 How can care givers support patients in making an informed choice between telemonitoring and standard care? Study design: This is a qualitative study using semi-structured interviews. Information about patient characteristics and potential factors that influence patients' ability or willingness to use IBD-CE will be collected. To guide the topics in the interview, three theories/models will be used: 1. The Unified Theory of Acceptance and Use of Technology (UTAUT) model 2. The COM-B model for behavioural change 3. The model of positive health Data will be analysed using thematic analysis. Study population: Consecutive adult IBD patients (> 18 years) in stable remission, visiting the outpatient clinic at the Jeroen Bosch Hospital and Franciscus Gasthuis & Vlietland will be asked if the patients are willing to participate. Next, a total of 24 patients will be included through purposeful sampling. Both patients unwilling to use IBD-CE and patients interested in IBD-CE will be included. Should data saturation not have occurred, more patients will be included. Expected results and relevance: The objective is to get better insights in the motivations of patients to choose for telemonitoring or standard care. This study aims to comprehend the requirements of patients to provide them with care that aligns with patients' needs.

NCT ID: NCT06117423 Recruiting - Ulcerative Colitis Clinical Trials

Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

GUIDE
Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Primary non-response to adalimumab is high in both CD and UC. Currently, there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of adalimumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled adalimumab (adalimumab-680LT). This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).

NCT ID: NCT06112353 Not yet recruiting - Intestinal Disease Clinical Trials

Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Start date: April 2024
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery

NCT ID: NCT06111131 Recruiting - Small Bowel Disease Clinical Trials

Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.

NCT ID: NCT06107179 Recruiting - Ulcerative Colitis Clinical Trials

Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Start date: January 24, 2024
Phase:
Study type: Observational

In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity. The goal of this clinical trial is to compare the optoacoustic signal in the intestinal wall of children with inflammatory bowel diseases. The main questions it aims to answer are: - How does the optoacoustic signal in children with inflammatory bowel diseases change over time? - How does the optoacoustic signal in children with inflammatory bowel diseases change when they receive therapy? Participants will be examined with multispectral optoacoustic tomography.