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: Individuals who meet all of the following criteria are eligible for enrollment as study participants: -Males or females >= 3 years of age. -If subject does not have an already established diagnosis of EoE, EoG, EoN, or EoC, must have ongoing clinical symptoms. Symptoms include, but are not limited to: -EoE-abdominal pain, vomiting, heartburn, feeding / eating problems, dysphagia, food impaction, -EoG- abdominal pain, vomiting, -EoN- abdominal pain, vomiting, diarrhea -EoC- hematochezia, bloody/non bloody diarrhea, tenesmus, abdominal pain Symptoms are not required for subjects with established EoE, EoG, EoN or EoC diagnoses. Symptoms are required for new EGID diagnoses; new diagnoses are defined as receiving a diagnostic endoscopy within 4 weeks of study enrollment. -Mucosal eosinophilia peak counts reaching the following thresholds in a diagnostic endoscopy: --For EoE subjects, (Bullet) 15 eosinophils/hpf in the distal or proximal esophagus. --For EoG subjects, (Bullet) 30 eosinophils/hpf in 5 hpf s in the body and/or antrum --For EoN subjects, (Bullet) 53 eosinophils/hpf in the duodenum and/or (Bullet) 56 eosinophils/hpf in the jejunum and/or ileum --For EoC subjects, (Bullet) 84 eosinophils/hpf from the transverse or descending colon and/or >= 32 eosinophils/hpf from the rectosigmoid colon or a biopsy from any colonic location with >= 100 eosinophils/hpf. Peak eosinophilia counts are based on the current diagnosing guidelines. These thresholds are subject to change as new research develops and guidelines are updated. EXCLUSION CRITERIA: Individuals who meet any of these criteria are not eligible for enrollment as study subjects: -Currently enrolled in a blinded investigational study at the time of the screening/enrollment/baseline visit. -Subjects with other identifiable potential causes for eosinophilia such as some cancers, intestinal worm and parasite infections and graft versus host disease. -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 that the potential subject has diminished capacity and is not cognitively able to participate fully in the consenting process -Subjects with inflammatory bowel disease (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 EoC, then the potential subject could enroll if all other inclusion/exclusion criteria are met. Subjects can enter blinded investigational trials at any point after completion of the baseline visit. The study team will record the dates of trial participation and continue to collect OMEGA study data during the period the subject participates in the trial.
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
-Males or females >= 3 years of age.
-If subject does not have an already established diagnosis of EoE, EoG, EoN, or EoC, must have ongoing clinical symptoms.
Symptoms include, but are not limited to:
-EoE-abdominal pain, vomiting, heartburn, feeding / eating problems, dysphagia, food impaction,
-EoG- abdominal pain, vomiting,
-EoN- abdominal pain, vomiting, diarrhea
-EoC- hematochezia, bloody/non bloody diarrhea, tenesmus, abdominal pain
Symptoms are not required for subjects with established EoE, EoG, EoN or EoC diagnoses. Symptoms are required for new EGID diagnoses; new diagnoses are defined as receiving a diagnostic endoscopy within 4 weeks of study enrollment.
-Mucosal eosinophilia peak counts reaching the following thresholds in a diagnostic endoscopy:
--For EoE subjects, (Bullet) 15 eosinophils/hpf in the distal or proximal esophagus.
--For EoG subjects, (Bullet) 30 eosinophils/hpf in 5 hpf s in the body and/or antrum
--For EoN subjects, (Bullet) 53 eosinophils/hpf in the duodenum and/or (Bullet) 56 eosinophils/hpf in the jejunum and/or ileum
--For EoC subjects, (Bullet) 84 eosinophils/hpf from the transverse or descending colon and/or >= 32 eosinophils/hpf from the rectosigmoid colon or a biopsy from any colonic location with >= 100 eosinophils/hpf.
Peak eosinophilia counts are based on the current diagnosing guidelines. These thresholds are subject to change as new research develops and guidelines are updated.
EXCLUSION CRITERIA:
Individuals who meet any of these criteria are not eligible for enrollment as study subjects:
-Currently enrolled in a blinded investigational study at the time of the screening/enrollment/baseline visit.
-Subjects with other identifiable potential causes for eosinophilia such as some cancers, intestinal worm and parasite infections and graft versus host disease.
-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 that the potential subject has diminished capacity and is not cognitively able to participate fully in the consenting process
-Subjects with inflammatory bowel disease (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 EoC, then the potential subject could enroll if all other inclusion/exclusion criteria are met.
Subjects can enter blinded investigational trials at any point after completion of the baseline visit. The study team will record the dates of trial participation and continue to collect OMEGA study data during the period the subject participates in the trial.
Principal Investigator
Referral Contact
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