ORAL TYPE 1 BOVINE COLLAGEN IN SCLERODERMA

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。所列机构为中心，不一定是研究者所在机构。这项拟议的研究是一项多中心II期临床试验，旨在确定口服500 mg/天的牛I型胶原蛋白（CI）是否会改善弥漫性系统性硬化症（SSc）。本研究采用随机、分层（针对疾病持续时间）、双盲、安慰剂对照的临床试验实验设计。患者将被分层：1例疾病持续时间小于或等于3年，1例疾病持续时间大于3年至（含）10年。 该提议将检验以下假设：口服CI将诱导SSc改善，并且口服饲喂牛CI将诱导弥漫性SSc患者的口服耐受性或外周血单核细胞对CI链的反应性下调。

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.