Indiana University Gastrointestinal Motility Diagnosis Registry
Eosinophilic EsophagitisGastroesophageal Reflux Disease (GERD)7 moreDevelop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders
A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24...
Eosinophilic OesophagitisThis is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) Screening period: Up to 12 weeks before Week 0 Randomized double-blind period: 24 weeks Open label period: 104 weeks Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first. There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
Systems Biology of Gastrointestinal and Related Diseases
Ulcerative ColitisCrohn Disease20 moreThis is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.
Validation in French of a Quality of Life Questionnaire for Patients With Eosinophilic Esophagitis...
Eosinophilic EsophagitisEosinophilic esophagitis is a chronic condition of the esophagus. The symptoms of eosinophilic esophagitis can affect the quality of life of affected children. There is no French scale to specifically evaluate the quality of life of these patients. It will be a monocentric, prospective, descriptive study carried out at the Nice University Pédiatric Hospital. The main objective of this study will be the validation of a French version of the quality of life pediatric scale (PedsQL) module for eosinophilic esophagitis. It will take place in 2 distinct parts: The translation of the questionnaire in French. Collection of the quality of life questionnaires
Examining the Effect of Ondansetron on Bowel Prep Success
Abdominal PainInflammatory Bowel Diseases4 moreThis is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.
Eosinophilic Gastrointestinal Disorders Registry
Eosinophilic EsophagitisEosinophilic Gastroenteritis2 moreThe purpose of this study is to learn more about Eosinophilic Gastrointestinal Disorders (EGIDs). With this registry we hope to find out more about the symptoms that patients have during their treatment, the quality of life they have with the diagnosis, what the disease looks like throughout the different treatment methods, and if there is a connection between EGIDs and connective tissue disorders. The goal of this study is to be able to better understand EGIDs and use information gained from all the information collected on this study for more precise treatments in the future. We want to create a large collection of samples, called a biorepository, to learn the most about EGIDs as possible. When the samples are collected, which will occur at procedures directed by your child's doctor as part of their standard of care, they will be stored for an unlimited amount of time to perform experiments on these samples and to gather information about EGIDs
Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults'...
Eosinophilic EsophagitisA phase I/II, multicenter, double-blind, parallel, randomized trial to assess pharmacokinetics, efficacy, tolerability and safety of different budesonide oral gel doses in adults subjects of both genders with eosinophilic esophagitis (EoE)
Natural History and Genetics of Food Allergy and Related Conditions
Food AllergyLoeys-Dietz Syndrome2 moreBackground: - About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them. Objective: - To learn more about the causes and effects of food allergy and related conditions. Eligibility: People ages 2 99 who have food allergy and/or a related genetic or other condition Their relatives Healthy relatives and volunteers Design: Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer. Participants will be screened with medical history, physical exam, and questionnaires. Participants may have the following: Blood tests Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop. Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm. X-rays Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour. EGD and colonoscopy: Biopsies are taken from the gastrointestinal system. Tiny biopsies of skin Photographs of the body Collection of cells through: Swab of nose, inside of cheek, or skin Gentle skin scrape Tape stripping: piece of tape is put on the skin and pulled off.
Eosinophilic Esophagitis Steroid Safety Study
Eosinophilic EsophagitisThis observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.
Esophageal String Test in Eosinophilic Esophagitis
Eosinophilic EsophagitisThe overall goal of this study is to develop a novel minimally invasive device, the Esophageal String Test (EST) to monitor esophageal inflammation during treatment of the rare disease Eosinophilic Esophagitis (EoE) in a safe and efficacious manner. This study is broken down into 2 specific aims: Specific Aim 1: Identify the EoE Biomarker Panel (EBP) that will improve the sensitivity and specificity of the EST for documenting esophageal inflammation in a 1-hour time point. Specific Aim 2: Validate the ability of the EST EBP to monitor therapeutic efficacy in a 1-hour sampling time. Funding Source - FDA OOPD