BSCU1 and Immune Function

NCT ID: NCT05403398

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2023-03-20

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.

Conditions

General Population

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BSCU1

B. subtilis CU1 at 2 billion CFUs daily for 4 weeks

Group Type: EXPERIMENTAL

B. subtilis CU1

Intervention Type: DIETARY_SUPPLEMENT

2 billion CFUs daily, for 4 weeks

Interventions

B. subtilis CU1

2 billion CFUs daily, for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

B. subtilis CNCM I-2745

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NIZO Food Research

OTHER

Sponsor Role: collaborator

Lesaffre International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François Jeanne

Role: STUDY_DIRECTOR

Lesaffre Group

Locations

NIZO food research BV

Ede, ZB, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 39151920 (View on PubMed)

Other Identifiers

NL79890.000.21

Identifier Type: -

Identifier Source: org_study_id