BSCU1 and Immune Function

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

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.

Study Overview

• Status: Completed
• Conditions: General Population
• Intervention / Treatment: Dietary supplement: B. subtilis CU1

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian Mourey; Phone Number: +33 (0)3 20 66 68 36; Email: f.mourey@gnosis.lesaffre.com

Study Locations

• Netherlands
  • ZB
    • Ede, ZB, Netherlands, 6718
      • NIZO food research BV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 79 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BSCU1; B. subtilis CU1 at 2 billion CFUs daily for 4 weeks	Dietary supplement: B. subtilis CU1; 2 billion CFUs daily, for 4 weeks; Other Names: B. subtilis CNCM I-2745

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal sIgA	Change in fecal sIgA concentration	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum cytokine concentration	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)	4 weeks
Ex-vivo cytokines concentration	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)	4 weeks
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
Fecal microbiota	Fecal microbiota composition using shotgun metagenomics sequencing	4 weeks
RNA sequencing	Gene expression in PBMC (RNA sequencing)	4 weeks
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

Collaborators and Investigators

• Sponsor: Lesaffre International
• Collaborators: NIZO Food Research
• Investigators: Study Director: Jean-François Jeanne, Lesaffre Group

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): October 18, 2022
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NL79890.000.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No