BSCU1 and Immune Function
- Conditions
- General Population
- Interventions
- Dietary Supplement: B. subtilis CU1
- Registration Number
- NCT05403398
- Lead Sponsor
- Lesaffre International
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BSCU1 B. subtilis CU1 B. subtilis CU1 at 2 billion CFUs daily for 4 weeks
- Primary Outcome Measures
Name Time Method Fecal sIgA 4 weeks Change in fecal sIgA concentration
- Secondary Outcome Measures
Name Time Method 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.
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
RNA sequencing 4 weeks Gene expression in PBMC (RNA sequencing)
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)
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)
Fecal microbiota 4 weeks Fecal microbiota composition using shotgun metagenomics sequencing
Trial Locations
- Locations (1)
NIZO food research BV
🇳🇱Ede, ZB, Netherlands