Active clinical trials for "Eosinophilic Esophagitis"

The aim of the present study is determining the accuracy, safety and tolerance of the CytospongeTM (expandable sponge within a gelatin capsule attached to a string) relative to traditional upper endoscopy and esophageal biopsies in older children and adolescents with a diagnosis of Eosinophilic Esophagitis (EoE) to follow up on treatment changes. The findings from this study could help determine whether the CytospongeTM is a more cost-effective alternative to traditional upper endoscopy for histologic follow-up in children and adolescents with EoE.

This is a randomized, double blind, sham-controlled, pilot/feasibility trial of individualized dietary elimination treatment.

This research is being done to see if patients with milk-triggered EoE are able to tolerate baked milk in their diet and if there is a threshold amount of straight milk that is tolerable.

Eosinophilic esophagitis (EoE) is a chronic, relapsing, immune-mediated esophageal disease. Clinical manifestations in infants and toddlers generally include vomiting, food refusal, choking with meals and, less commonly, failure to thrive. The management of the disease includes dietary and pharmaceutical interventions, and the goal of the treatment should ideally be both the resolution of symptoms and the normalization of the macroscopic and microscopic abnormalities. Milk is the most common food trigger identified, followed by wheat, soy, and eggs. The aim of the study is to examine the tolerability of a new plant based formula made of minimally processed almond and buckwheat and enriched with vitamins and minerals.

Prospective, pragmatic standard of care clinical trial comparing dietary therapies of standard dairy elimination diet alone (DED) to dairy elimination plus food additive elimination (FREE)

This is a randomized, placebo-controlled, double-blind trial to evaluate the efficacy, tolerability, and safety of ESO-101 in adult patients with active eosinophilic esophagitis (EoE). Patients will be screened at 2 visits (Visit 1 and Visit 2) during which their eligibility will be assessed based on endoscopy-independent criteria (Visit 1) and based on the histologic assessment of esophageal biopsy samples taken during the screening endoscopy (Visit 2). Eligible patients will be randomized 2:1 to once-daily treatment with ESO-101 or placebo and treated for 28 days starting on Day 0. Further clinic visits will be performed at Day 14 (Visit 4) and Day 28 (Visit 5, end of treatment) to assess the efficacy, tolerability, and safety. In addition, a safety follow-up call will be scheduled 2 weeks after the end of treatment (Day 42, Visit 6).

The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation To study the effects of dupilumab on the type 2 inflammation gene expression signature To evaluate the concentration-time profile of functional dupilumab in serum in this population To assess efficacy of long-term (up to 160 weeks) dupilumab treatment To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment To evaluate the impact of dupilumab treatment on EoE signs and symptoms

Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms: Placebo for Induction and Maintenance CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance CC-93538 360 mg SC once weekly for Induction and Maintenance

This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.

Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers