BSCU1 and Immune Function

NCT05403398 | Completed

• 1 other identifier: NL79890.000.21
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

General Population

Outcome Measures

Primary Outcomes (1)

• Fecal sIgA

  Change in fecal sIgA concentration

  4 weeks

Secondary Outcomes (6)

• Serum cytokine concentration

  4 weeks

• Ex-vivo cytokines concentration

  4 weeks

• Ex-vivo phagocytosis

  4 weeks

• Fecal microbiota

  4 weeks

• RNA sequencing

  4 weeks

Study Arms (1)

BSCU1

EXPERIMENTAL

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

Dietary Supplement: B. subtilis CU1

Interventions

B. subtilis CU1 DIETARY_SUPPLEMENT

2 billion CFUs daily, for 4 weeks

Also known as: B. subtilis CNCM I-2745

BSCU1

Eligibility Criteria

• Age: 3 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• ≤ 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
• ≤ 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
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lesaffre International: lead
• NIZO Food Research: collaborator

Study Sites (1)

NIZO food research BV

Ede, ZB, 6718, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39151920 DERIVED

Study Officials

• Jean-François Jeanne

  Lesaffre Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 3, 2022
• Study Start: June 7, 2022
• Primary Completion: October 18, 2022
• Study Completion: March 20, 2023
• Last Updated: January 8, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)