BSCU1 and Immune Function

General Population Clinical Trial

Official title:

Change in Markers of Immune Function Associated With Bacillus Subtilis CU1 Intervention in Different Age Groups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403398
• Other study ID #: NL79890.000.21
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• General Population

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