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 study is a multi-center Phase II clinical trial to determine whether oral bovine type I collagen (CI) at 500 g/day will improve diffuse systemic sclerosis (SSc). The study employs a randomized, stratified (for disease duration), double-blind, placebo-controlled, clinical trial experimental design. There are 10 participating centers. There are 9 clinical centers and 3 cores. Patients will be stratified into groups: one with disease duration <= 3 yr and one with disease duration of >3 to and including 10 yrs. 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 PBMC reactivity to CI a chains in patients with diffuse SSc. 168 patients with diffuse SSc of <= yrs or > 3 <= 10 years duration will be stratified and randomized to receive daily placebo [2 ml 0.1 M acetic acid (HAc)] or 500 g bovine CI for 12 months. Patients will have screening, baseline, 4, 8, 12, and 15 mo. measurements of modified Rodnan skin score (MRSS) as a primary clinical outcome variable and Scleroderma Health Assessment Questionnaire (SHAQ)-a, short form 36 questionnaire, Physician's Global Assessment, Patient's Global Assessment, blood pressure, weight and serum creatinine determinations as secondary clinical outcome measures. For patients dropping out of the study greater than or equal to 6 months and less than or equal to 11 months, these primary and secondary clinical outcome measures will be obtained at the time of drop-out and at 12 and 15 months. Patients will have FVC and DLCO measured at baseline, 0 and at 12 months or at dropout from the study and at 12 months as secondary clinical outcome parameters. Sera and PBMC will be obtained before and after 12 months treatment with oral bovine CI. The PBMC will be cultured with and without bovine a1 (I) and a2 (I) chains and native bovine CI. The sera and PBMC supernatants will be analyzed by ELISA for IFN? and IL-10, at baseline and 12 months. Decreases in IFN? or IL-10 production by a chain-stimulated PBMC after oral CI will be the primary immunology outcome variable. IL-2R levels will be measured in serum of SSc patients at baseline and 12 months as a secondary immunology outcome variable.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR020359-02
Application #
7376120
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
2
Fiscal Year
2006
Total Cost
$1,033
Indirect Cost
Name
Children's Research Institute
Department
Type
DUNS #
143983562
City
Washington
State
DC
Country
United States
Zip Code
20010
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Mullins, Tanya L Kowalczyk; Li, Su X; Bethel, James et al. (2018) Sexually transmitted infections and immune activation among HIV-infected but virally suppressed youth on antiretroviral therapy. J Clin Virol 102:7-11
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Ruan, Alexandra; Tobin, Nicole H; Mulligan, Kathleen et al. (2016) Brief Report: Macrophage Activation in HIV-Infected Adolescent Males Contributes to Differential Bone Loss by Sex: Adolescent Trials Network Study 021. J Acquir Immune Defic Syndr 72:372-5
Orrock, Janet E; Panchapakesan, Karuna; Vezina, Gilbert et al. (2016) Association of brain injury and neonatal cytokine response during therapeutic hypothermia in newborns with hypoxic-ischemic encephalopathy. Pediatr Res 79:742-7
Sepeta, Leigh N; Berl, Madison M; Wilke, Marko et al. (2016) Age-dependent mesial temporal lobe lateralization in language fMRI. Epilepsia 57:122-30

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