3 result(s) found
This study is being conducted to test the efficacy and safety of AK002 in patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis and requires nine study visits over the course of 24 weeks. Participants will receive study drug or placebo via infusion during four of these visits.
Eosinophilic Esophagitis (EoE) is a swallowing disorder which is caused by an allergy-like inflammation of the esophagus. It is diagnosed by esophageal biopsies and can be treated with anti-inflammatory medicines. There are cases of EoE in children and adults and the symptoms primarily present with difficulty swallowing or the feeling of food being stuck in the esophagus. Currently there is no exact way to define the activity of Eosinophilic Esophagitis. An activity index for measuring the disease severity has not been developed so there is difficulty in measuring the treatment responses in clinical studies. The creation of an Activity Index (or a score) for EoE will allow the objective measurement of patient symptoms.
The aim of the current multi-center study is to develop, validate and evaluate an EoE activity index for pediatric and adult patients. Our site at Tufts will soley be involved in the adult population of patients with EoE. The study is purely observational and involves undergoing a structured interview from the research coordinator involved in the study in addition to the standard medical care (including medicines, endoscopic evaluations and biopsies, for example) by one of the investigators of the study. There is also a questionnaire that the patients will have to fill out. There are several items in the questionnaire measuring the symptoms (eg frequency of dysphagia, dysphagia in relation to distinct food consistencies). There is also a component where the biologic activity (number of eosinophils in esophageal biopsy or presence of signs of acute inflammation in esophagoscopy) will be incorporated. The biologic activity component will be completed by the principal or co-investigators who are caring for the patients.
Inflammatory Bowel Disease
Characterization of anaerobic microorganisms in the bowel of patients with inflammatory bowel disease.