Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy

Environmental enteric dysfunction (EED) is a poorly understood condition characterized by
intestinal inflammation and loss of barrier function that is prevalent in regions of the
world with inadequate sanitation and hygiene. EED is a major driver of malnourishment, poor
neurological development, stunting, oral vaccine failure, and infection, affecting 25% of all
children globally and causing over a million deaths each year.

Progress towards understanding EED and developing effective interventions has been hampered
by an inability to evaluate the intestinal mucosa of populations in impoverished regions of
the world where this condition is endemic. In order to prevent the deleterious and permanent
sequelae of the disease, there is a need for effective diagnosis and intervention to be
implemented in EED patients before the age of 2. Currently, the only means for directly
evaluating the intestine is endoscopy with mucosal biopsy. Unfortunately, endoscopy is
untenable for the study of EED because of limited resources and the high cost. As a result,
there is a clear, unmet need for a less invasive tool that can be used in
low-and-middle-income-countries (LMICs) to evaluate the intestine in population with EED.

This work is supported by a grant from The Bill and Melinda Gates Foundation (BMGF). The
overall goal is to provide a minimally invasive means of obtaining detailed infantile
intestinal tissue information that is needed for the development of effective EED
interventions. Obtaining biopsies will play a critical role in gathering the detailed
intestinal tissue information.

The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to
obtain biopsies in adults.