This study is currently recruiting participants.
Number
19-I-0022
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 3 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Gastrointestinal Disorders; Eosinophilic Gastroenteritis; Mucosal Eosinophil Count; Transcriptome; Histology; Natural History
Recruitment Keyword(s)
Condition(s)
Eosinophilic Esophagitis (EoE); Eosinophilic Gastroenteritis (EGE); Eosinophilic Colitis (EC); Eosinophilic Gastritis (EoG)
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
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Inclusion Criteria: Males or females 3 years of age and older If subject does not have an already established diagnosis of EoE, EG, EGE, or EC, must have ongoing clinical symptoms. Symptoms include, but are not limited to: -EoE-abadominal pain, vomiting, heartburn, feeding/eating problems, dysphagia, food impaction -EG - abdominal pain, vomiting -EGE-abdominal pain, vomiting diarrhea -EC-hematochezia, bloody/non bloody diarrhea, tenesmus, abdominal pain Mucosal eosinophilia peak counts reaching the following thresholds in a diagnostic endoscopy: -For EoE subjects>=15 eosinophils/hpf in the distal or proximal esophagus. -For EG subjects, >=30 eosinophils/hpf in 5 hpf's in the body and/or antrum -For EGE subjects, >=53 eosinophils/hpf in the duodenum and/or >=56 eosinophils/hpf in the jejunum and/or ileum -For EC subjects, >=84 eosinophils/hpf from the transverse or descending colong and/or >=32 eosinophils/hpf from the rectosigmoid colon or a biopsy from any colonic location with >=100 eosinophils/hpf Subjects with EC enrolled prior to Protocol Version 5.0 with <65 eosinophils in the rectosignoid colon but have >=32 eosinophils/hpf from the rectosigmoid colo Exclusion Criteria: History of intestinal surgery other than G tube placement Currently enrolled in a blinded investigational study at the time of the screening/enrollment/baseline visit Esophageal stricture <3mm Subjects with other identifiable potential causes for eosinophilia except IBD. In the case of IBD, investigators will review the clinical history, serology and accompanying biopsies to determine if the diagnosis captures UC/Crohn's diagnosis in the context of the histological finding of mucosal eosinophilia. If the assessment suggests that the subject clearly has ulcerative colitis or Crohn's disease, the subject will not be enrolled. If the assessment suggests the subject may have EC, then the potential subject could enroll if all other inclusion/exclusion criteria are met. Any physical, mental or social condition, history or concurrent illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study. Potential subjects will be excluded if the investigator determines thta the potential subject has diminished capacity and is not cognitively able to participate fully in the consenting process.
Males or females 3 years of age and older
If subject does not have an already established diagnosis of EoE, EG, EGE, or EC, must have ongoing clinical symptoms. Symptoms include, but are not limited to:
-EoE-abadominal pain, vomiting, heartburn, feeding/eating problems, dysphagia, food impaction
-EG - abdominal pain, vomiting
-EGE-abdominal pain, vomiting diarrhea
-EC-hematochezia, bloody/non bloody diarrhea, tenesmus, abdominal pain
Mucosal eosinophilia peak counts reaching the following thresholds in a diagnostic endoscopy:
-For EoE subjects>=15 eosinophils/hpf in the distal or proximal esophagus.
-For EG subjects, >=30 eosinophils/hpf in 5 hpf's in the body and/or antrum
-For EGE subjects, >=53 eosinophils/hpf in the duodenum and/or >=56 eosinophils/hpf in the jejunum and/or ileum
-For EC subjects, >=84 eosinophils/hpf from the transverse or descending colong and/or >=32 eosinophils/hpf from the rectosigmoid colon or a biopsy from any colonic location with >=100 eosinophils/hpf
Subjects with EC enrolled prior to Protocol Version 5.0 with <65 eosinophils in the rectosignoid colon but have >=32 eosinophils/hpf from the rectosigmoid colo
Exclusion Criteria:
History of intestinal surgery other than G tube placement
Currently enrolled in a blinded investigational study at the time of the screening/enrollment/baseline visit
Esophageal stricture <3mm
Subjects with other identifiable potential causes for eosinophilia except IBD. In the case of IBD, investigators will review the clinical history, serology and accompanying biopsies to determine if the diagnosis captures UC/Crohn's diagnosis in the context of the histological finding of mucosal eosinophilia. If the assessment suggests that the subject clearly has ulcerative colitis or Crohn's disease, the subject will not be enrolled. If the assessment suggests the subject may have EC, then the potential subject could enroll if all other inclusion/exclusion criteria are met.
Any physical, mental or social condition, history or concurrent illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study.
Potential subjects will be excluded if the investigator determines thta the potential subject has diminished capacity and is not cognitively able to participate fully in the consenting process.
Principal Investigator
Referral Contact
For more information: