Clinical trial NCT05403398: BSCU1 and Immune Function
Official title: Change in Markers of Immune Function Associated With Bacillus Subtilis CU1 Intervention in Different Age Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Population
Lead sponsor: Lesaffre International
Sponsor class: INDUSTRY
Collaborators: name: NIZO Food Research
First posted: 2022-06-03
Enrollment: 89
Sex: ALL
Minimum age (years): 3
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fecal sIgA
timeFrame: 4 weeks
Secondary outcomes:
measure: Serum cytokine concentration
timeFrame: 4 weeks
measure: Ex-vivo cytokines concentration
timeFrame: 4 weeks
measure: Ex-vivo phagocytosis
timeFrame: 4 weeks
measure: Fecal microbiota
timeFrame: 4 weeks
measure: RNA sequencing
timeFrame: 4 weeks
measure: Immune cell phenotyping
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: NIZO food research BV
state: ZB
Study officials:
affiliation: Lesaffre Group
name: Jean-François Jeanne
role: STUDY_DIRECTOR
References: