The current study aims to explore a range of possible pathways by which BSCU1 could beneficially modulate the immune system, in three target populations representing the general population.
This exploratory study is designed as a single-arm study with repeated measures, involving three different populations, in which each subject serves as its own control. The duration of the intervention is 4 weeks, with biomarker assessments at baseline, after 2 weeks, and after 4 weeks intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
89
2 billion CFUs daily, for 4 weeks
NIZO food research BV
Ede, ZB, Netherlands
Fecal sIgA
Change in fecal sIgA concentration
Time frame: 4 weeks
Serum cytokine concentration
Change in serum cytokines concentration (e.g. MIP-1α, IL-6, Il-10, IFN-γ, TNF-α, IL-1β) in elderly using a commercial Multiplex Bead Immunoassay (Bio-Rad, Veenendaal, The Netherlands)
Time frame: 4 weeks
Ex-vivo cytokines concentration
Change in control and Lipopolysaccharide (LPS) stimulated cytokine (e.g. MIP-1α, IL-6, Il-10, IFN-γ, TNF-α, IL-1β) production in whole blood in adults and elderly using a commercial Multiplex Bead Immunoassay (Bio-Rad, Veenendaal, The Netherlands)
Time frame: 4 weeks
Ex-vivo phagocytosis
Ex-vivo phagocytic function of monocytes and granulocytes using the commercial pHrodo, BioParticles phagocytosis assay kit (Invitrogen, ThermoFisher) for flow cytometry
Time frame: 4 weeks
Fecal microbiota
Fecal microbiota composition using shotgun metagenomics sequencing
Time frame: 4 weeks
RNA sequencing
Gene expression in PBMC (RNA sequencing)
Time frame: 4 weeks
Immune cell phenotyping
Immune cell phenotyping will be performed by labelling of the cell with cell specific markers and measured by means of flow cytometry. Two panels of each 8-12 markers will be used for general cell phenotyping, including activation markers, and T cell specific phenotyping in PBMCs.
Time frame: 4 weeks
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