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General PopulationNCT05403398

BSCU1 and Immune Function

A study testing B. subtilis CU1 in people with General Population, run by Lesaffre International at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 79 yearsHealthy volunteers can take part
Conditions the study is for
General Population
What is being tested?
B. subtilis CU1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteNetherlands
Study dates
7 Jun 2022to 20 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • NIZO food research BV

    Ede, ZB, 6718

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
B. subtilis CU1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B. subtilis CU1Dietary supplement

    Also called B. subtilis CNCM I-2745

    2 billion CFUs daily, for 4 weeks

Study groups in NCT05403398
Study groupRoleWhat they receive
BSCU1ExperimentalB. subtilis CU1 at 2 billion CFUs daily for 4 weeks
Receives: Dietary Supplement: B. subtilis CU1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fecal sIgA

    Change in fecal sIgA concentration

    Measured: 4 weeks

Secondary outcomes (6)

  1. 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)

    Measured: 4 weeks

  2. 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)

    Measured: 4 weeks

  3. Ex-vivo phagocytosis

    Ex-vivo phagocytic function of monocytes and granulocytes using the commercial pHrodo, BioParticles phagocytosis assay kit (Invitrogen, ThermoFisher) for flow cytometry

    Measured: 4 weeks

  4. Fecal microbiota

    Fecal microbiota composition using shotgun metagenomics sequencing

    Measured: 4 weeks

  5. RNA sequencing

    Gene expression in PBMC (RNA sequencing)

    Measured: 4 weeks

  6. 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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start7 Jun 2022
  3. Primary completion18 Oct 2022
  4. Study completion20 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05403398
Sponsor's protocol ID
NL79890.000.21
Status last verified
May 2022
First submitted
20 May 2022
Last updated
8 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mourey F, Scholtens P, Jeanne JF, Rodriguez B, Decherf A, Machuron F, Kardinaal A, Scheithauer T, Porbahaie M, Narni-Mancinelli E, Crinier A. The probiotic strain Bacillus subtilis CU1 primes antimicrobial innate immune response and reduces low-grade inflammation: a clinical study. Benef Microbes. 2024 Aug 14;15(6):659-678. doi: 10.1163/18762891-bja00028.

    PubMed 39151920

Questions about this trial

What is this clinical trial studying?

A study testing B. subtilis CU1 in people with General Population, run by Lesaffre International at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fecal sIgA (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.

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