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| Name | Class |
|---|---|
| NIZO Food Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSCU1 | Experimental | B. subtilis CU1 at 2 billion CFUs daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. subtilis CU1 | Dietary Supplement | 2 billion CFUs daily, for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal sIgA | Change in fecal sIgA concentration | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 weeks |
| Ex-vivo cytokines concentration |
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Inclusion Criteria:
Adults
Elderly
Children
Exclusion Criteria:
Adults and elderly
Children
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François Jeanne | Lesaffre Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIZO food research BV | Ede | ZB | 6718 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39151920 | Derived | Mourey F, Scholtens P, Jeanne JF, Rodriguez B, Decherf A, Machuron F, Kardinaal A, Scheithauer T, Porbahaie M, Narni-Mancinelli E, Crinier A. The probiotic strain Bacillus subtilis CU1 primes antimicrobial innate immune response and reduces low-grade inflammation: a clinical study. Benef Microbes. 2024 Aug 14;15(6):659-678. doi: 10.1163/18762891-bja00028. |
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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) |
| 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 | 4 weeks |
| Fecal microbiota | Fecal microbiota composition using shotgun metagenomics sequencing | 4 weeks |
| RNA sequencing | Gene expression in PBMC (RNA sequencing) | 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. | 4 weeks |