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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05403398
Other study ID # NL79890.000.21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2022
Est. completion date March 20, 2023

Study information

Verified date May 2022
Source Lesaffre International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
B. subtilis CU1
2 billion CFUs daily, for 4 weeks

Locations

Country Name City State
Netherlands NIZO food research BV Ede ZB

Sponsors (2)

Lead Sponsor Collaborator
Lesaffre International NIZO Food Research

Country where clinical trial is conducted

Netherlands, 

Outcome

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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