ORAL TYPE 1 BOVINE COLLAGEN IN SCLERODERMA

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项拟议的研究是一项多中心的II期临床试验，旨在确定每天500毫克的口服牛I型胶原(CI)是否会改善弥漫性系统性硬化症(SSC)。该研究采用了随机、分层(疾病持续时间)、双盲、安慰剂对照的临床试验实验设计。患者将被分成两组：一组病程小于或等于3年，另一组病程大于3年至(含)10年。这一建议将检验口服CI将导致SSC改善的假设，以及口服牛CI将导致弥漫性SSC患者的口服耐受或外周血单个核细胞对CI链的反应性下调的假说。

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. This proposed study is a multi-center Phase II clinical trial to determine whether oral bovine type I collagen (CI) at 500 mg/day will improve diffuse systemic sclerosis (SSc). The study employs a randomized, stratified (for disease duration), double-blind, placebo-controlled, clinical trial experimental design. Patients will be stratified into groups: one with disease duration less than or equal to 3 years and one with disease duration of more than 3 years to (and including) 10 years. This proposal will test the hypothesis that oral CI will induce improvement in SSc, and that oral feeding of bovine CI will induce oral tolerance or downregulation of Peripheral blood mononuclear cell reactivity to CI chains in patients with diffuse SSc.