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Principal Investigator: Alan Leichtner, MD, FAAP
Protocol Title: Clinical Outcomes of Children with Marsh 1 Histopathology
Protocol Status: Closed for Recruitment
Trial Description: The purpose of this study is to determine the frequency of diagnosis of celiac disease in patients identified as having Marsh I histopathology following endoscopy. The histopathology of celiac disease is assessed using the Marsh classification. Marsh categories II-IIIc are characterized by intraepithelial lymphocytosis, crypt hyperplasia, and variable atrophy of the intestinal villi. Marsh I lesions are characterized by an abundance of intra-epithelial lymphocytes, yet the architecture is preserved. It is currently unclear if children who exhibit exclusively Marsh 1 lesions ultimately progress to fulminant celiac disease. Secondary outcomes include categorization of intraepithelial lymphocyte count and distribution within the villi, serum antibody measurements (if previously available), initiation of and adherence to a gluten-free diet, symptom control and quality of life.
Study procedures: Participants having undergone first upper endoscopy will be asked to take a survey.
Compensation: $10 dollar gift card to Target.
Recruitment Info: Children and adults from the ages of 12 months – 21 years who had first upper endoscopy between January 2001 through December 2005. Participants must have had either completely normal histology throughout the small intestine or Marsh I lesions in duodenum, confirmed by reinterpretation by the study pathologist.
Recruitment Contact Name: Caitlin McCarty
Recruitment Contact Phone: 617-355-8881
Recruitment Contact Email: firstname.lastname@example.org
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