General Population
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTB. subtilis CU1
2 billion CFUs daily, for 4 weeks
Sponsors
NIZO Food Research
Lesaffre International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
Adults * 30 ≤ age ≤ 49 years * BMI ≥ 18.5 and ≤ 25 kg/m2 * In good health as assessed during screening (by questionnaire), and the medical investigator's professional judgment * Non-smoking Elderly * 65 ≤ age ≤ 79 years * BMI ≥ 22.0 and ≤ 28.0 kg/m2 * Generally healthy as assessed during screening (by questionnaire), and the medical investigator's professional judgment * Non-smoking Children * 3 ≤ age ≤ 6 years * Healthy BMI, cut-off points will be used as indicated by JGZ * Generally healthy as assessed during screening (by parental anamnesis), and the study physician's professional judgment
Exclusion criteria
Adults and elderly * Chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer, chronic kidney or liver disease), * Acute infection in the past month * Gastrointestinal disorders (e.g., inflammatory bowel disease), * Acute gastroenteritis in the past 2 months * Any vaccination in the past month or any scheduled vaccination during the study period * Treatment with antibiotics within 2 months before the start of the study and during the study period * Regular use of laxative agents * Immunodeficiency disorder * Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic corticosteroids, antibodies) * Unexplained weight loss or weight gain of \> 3 kg in the 3 months prior to pre-study screening * Regular consumption of probiotics within 1 month before start of the study * Evidence of current excessive alcohol consumption (\>4 consumptions/day or \>20 consumptions/week) or drug (ab)use * Mental status that is incompatible with the proper conduct of the study Children * Acute respiratory or gastrointestinal infection in the past month * Chronic illness (e.g. chronic infections, systemic or metabolic disease) * Gastrointestinal disorders (e.g., inflammatory bowel disease), * Acute gastroenteritis in the past 2 months * Any vaccination in the past month or any scheduled vaccination during the study period * Treatment with antibiotics within 2 months before the start of the study and during the study period * Immunodeficiency disorder * Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic corticosteroids, antibodies) * Regular use of laxative agents * Regular consumption of probiotics within 1 month before start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal sIgA | 4 weeks | Change in fecal sIgA concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ex-vivo cytokines concentration | 4 weeks | 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) |
| Ex-vivo phagocytosis | 4 weeks | Ex-vivo phagocytic function of monocytes and granulocytes using the commercial pHrodo, BioParticles phagocytosis assay kit (Invitrogen, ThermoFisher) for flow cytometry |
| Serum cytokine concentration | 4 weeks | 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) |
| RNA sequencing | 4 weeks | Gene expression in PBMC (RNA sequencing) |
| Immune cell phenotyping | 4 weeks | 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. |
| Fecal microbiota | 4 weeks | Fecal microbiota composition using shotgun metagenomics sequencing |
Countries
Netherlands
Outcome results
None listed