RX OF CROHN'S DISEASE W/GROWTH HORMONE RELEASING HORMONE VS PLACEBO

克罗恩病的治疗与生长激素释放激素对比安慰剂

• 批准号: 7606382
• 负责人: EMILY C WALVOORD
• 金额: $ 0.31万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606382
• 关键词: Adverse effects; Affect; Anterior Pituitary Gland; Attention; Bone Density; Cells; Chronic; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Condition; Crohn' s disease; Daily; Diet; Double-Blind Method; End Point; Etiology; Funding; Gastrointestinal tract structure; Geref; Grant; Growth; Inflammatory; Injection of therapeutic agent; Institution; Laboratories; Measures; Patients; Peptides; Pharmaceutical Preparations; Placebos; Proteins; Purpose; Randomized; Research; Research Personnel; Resources; Severity of illness; Somatotropin; Somatotropin-Releasing Hormone; Somatropin; Source; Testing; United States National Institutes of Health; hormone analog; improved; indexing; prospective; r-hGH-M

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 somatrope 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 克罗恩病是一种病因不明的慢性炎症性疾病，影响胃肠道的各个方面。 目前的治疗方法无法治愈，并且以多种副作用为代价;因此，需要进行研究以确定更有效的治疗方法。 重组人生长激素（GH）作为治疗的可能性最近受到关注。 在克罗恩病患者中使用GH和高蛋白饮食的初步研究结果表明，GH可能对这些患者的治疗有益^[1]。 生长激素释放激素（GHRH），一种刺激垂体前叶的体细胞合成和分泌生长激素的肽，也天然存在于肠道中。 目前尚不清楚GHRH是否在肠道中具有局部作用。 我们假设，人生长激素或生长激素释放激素治疗将有利于克罗恩病患者的疾病严重程度降低，改善生长，增加骨密度。 如果GHRH在肠道局部起作用，它可能会带来额外的好处。 本研究的目的是在一项前瞻性、随机、双盲临床试验中检验我们的假设。 在6个月的观察期后，患者将被随机分配至三组之一，每天接受GH（药物）、GEREF（GHRH类似物）或稀释剂（安慰剂）注射，持续6个月。 主要终点是克罗恩病活动指数（CDAI）的变化，该指数使用临床和实验室标准评估疾病的严重程度。