A Study to Investigate Safety and Tolerability of NDX-3315 in Healthy Participants and Patients...
Eosinophilic EsophagitisAn open-label phase 1b study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 in healthy participants and patients with eosinophilic esophagitis (EoE).
Comparison of Histology From a Mesh Sponge and Traditional Esophageal Biopsies in Children and Adolescents...
Eosinophilic EsophagitisThe 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.
The Immune Directed Individualized Elimination Therapy (iDIET) Study
Eosinophilic EsophagitisEoEThis is a randomized, double blind, sham-controlled, pilot/feasibility trial of individualized dietary elimination treatment.
A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis
Eosinophilic EsophagitisThis 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.
The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric...
Eosinophilic EsophagitisEosinophilic 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.
Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis...
Oral Cavity CancerHead and Neck Cancers - Tonsils6 moreAs mentioned above, several prior studies have shown the positive effects of oral use of aloe vera juice in managing chemotherapy and radiation-induced oral mucositis and esophagitis. This study aims to add to the existing body of research around aloe vera juice and its effects on oral mucositis and esophagitis. The intention is to determine whether aloe vera juice should be considered as part of standard treatment.
Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural...
Gastroesophageal Reflux DiseaseGERD4 moreThis study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis
Eosinophilic EsophagitisProspective, pragmatic standard of care clinical trial comparing dietary therapies of standard dairy elimination diet alone (DED) to dairy elimination plus food additive elimination (FREE)
A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis...
Eosinophilic EsophagitisThis 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).
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic...
Eosinophilic Esophagitis (EoE)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