BSCU1 and Immune Function

January 4, 2024 updated by: Lesaffre International

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fecal sIgA
Time Frame: 4 weeks
Change in fecal sIgA concentration
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum cytokine concentration
Time Frame: 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)
4 weeks
Ex-vivo cytokines concentration
Time Frame: 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)
4 weeks
Ex-vivo phagocytosis
Time Frame: 4 weeks
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
Time Frame: 4 weeks
Fecal microbiota composition using shotgun metagenomics sequencing
4 weeks
RNA sequencing
Time Frame: 4 weeks
Gene expression in PBMC (RNA sequencing)
4 weeks
Immune cell phenotyping
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lesaffre International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NIZO Food Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jean-François Jeanne, Lesaffre Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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