This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Crohn's disease is a chronic inflammatory condition of unknown etiology affecting all aspects of the gastrointestinal tract. Current treatment offers no cure and comes at the expense of multiple side effects; therefore, research to identify more effective therapies is needed. The possibility of recombinant human growth hormone (GH) as a treatment has received attention recently. Results from a preliminary study using GH and a high protein diet in patients with Crohn's disease suggest that GH may be beneficial in the treatment of these patients^1. Growth hormone release hormone (GHRH), a peptide that stimulates the synthesis and secretion of growth hormone from the somatotrope cells of the anterior pituitary gland, is also naturally found in the gut. It is not known if GHRH has local actions in the gut. We hypothesize that treatment with human growth hormone or growth hormone releasing hormone will be beneficial to patients with Crohn's disease by decreasing disease severity, improving growth, and increasing bone mineral density. GHRH may have added benefit if it acts locally in the gut. The purpose of this study is to test our hypothesis in a prospective, randomized, double blind clinical trial. After a 6-month observation period, patients will be randomized to one of three groups to receive daily injections of GH (drug), GEREF (GHRH analog), or diluent (placebo) for a period of 6 months. The primary end point to be measured is the change in the Crohn's disease activity index (CDAI), which assesses the severity of disease using clinical and laboratory criteria.
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