MULTI-CNTER PHASE 2 TRIAL OF ORAL TYPE I BOVINE COLLAGE

口服 I 型牛拼贴的多中心 2 期试验

• 批准号: 6158952
• 负责人: ARNOLD E POSTLETHWAITE
• 金额: $ 1.12万
• 依托单位: UNIVERSITY OF TENNESSEE HEALTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-29 至 2004-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6158952
• 关键词: clinical research; collagen; connective tissue disorder chemotherapy; dietary supplements; drug screening /evaluation; human subject; human therapy evaluation; immunopathology chemotherapy; nutrition related tag; oral administration; systemic scleroderma

The investigators propose to conduct a multi-center Phase II study to test the efficacy of oral collagen in systemic sclerosis (SSc). The primary outcome is change in Modified Rodman Skin Score. Other outcomes include pulmonary function tests, creatinine levels, and scleroderma questionnaires. In addition, studies are proposed to explore the underlying mechanisms that mediate a potential effect of oral collagen peptides in the immune pathogenesis of SSc.

研究人员建议开展一项多中心II期研究，以测试口服胶原蛋白对系统性硬化症（SSc）的疗效。主要结果是修改罗德曼皮肤评分的变化。其他结果包括肺功能检查、肌酐水平和硬皮病问卷调查。此外，研究人员还提出了探索口服胶原肽在SSc免疫发病机制中介导潜在作用的潜在机制。