ORAL TYPE 1 BOVINE COLLAGEN IN SCLERODERMA

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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.