General Population Clinical Trial
Official title:
Change in Markers of Immune Function Associated With Bacillus Subtilis CU1 Intervention in Different Age Groups
Verified date | May 2022 |
Source | Lesaffre International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | March 20, 2023 |
Est. primary completion date | October 18, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | NIZO food research BV | Ede | ZB |
Lead Sponsor | Collaborator |
---|---|
Lesaffre International | NIZO Food Research |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fecal sIgA | Change in fecal sIgA concentration | 4 weeks | |
Secondary | Serum cytokine concentration | Change in serum cytokines concentration (e.g. MIP-1a, IL-6, Il-10, IFN-?, TNF-a, IL-1ß) in elderly using a commercial Multiplex Bead Immunoassay (Bio-Rad, Veenendaal, The Netherlands) | 4 weeks | |
Secondary | Ex-vivo cytokines concentration | Change in control and Lipopolysaccharide (LPS) stimulated cytokine (e.g. MIP-1a, IL-6, Il-10, IFN-?, TNF-a, IL-1ß) production in whole blood in adults and elderly using a commercial Multiplex Bead Immunoassay (Bio-Rad, Veenendaal, The Netherlands) | 4 weeks | |
Secondary | 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 | |
Secondary | Fecal microbiota | Fecal microbiota composition using shotgun metagenomics sequencing | 4 weeks | |
Secondary | RNA sequencing | Gene expression in PBMC (RNA sequencing) | 4 weeks | |
Secondary | 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 |
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