NCT05403398 is a NA clinical trial of B. subtilis CU1 in General Population, sponsored by Lesaffre International.

Who is sponsoring NCT05403398?

NCT05403398 is sponsored by Lesaffre International.

What drugs are being tested in NCT05403398?

Interventions in NCT05403398: B. subtilis CU1.

What condition does NCT05403398 study?

NCT05403398 studies General Population.

Is NCT05403398 still recruiting?

NCT05403398 is currently completed. Last updated 8 January 2024.

Last reviewed 2024-01-08 · How we verify

NCT05403398

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BSCU1 and Immune Function

Completed NA Last updated 8 January 2024

What this trial tests

NA trial testing B. subtilis CU1 in General Population in 89 participants. Completed in 20 March 2023.

Timeline

7 June 2022

Primary endpoint
18 October 2022

20 March 2023

Quick facts

Lead sponsor	Lesaffre International
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	89
Start date	7 June 2022
Primary completion	18 October 2022
Estimated completion	20 March 2023
Sites	1 location across Netherlands

Drugs / interventions tested

B. subtilis CU1

Conditions studied

General Population — all drugs for General Population →

Sponsor

Lesaffre International — full company profile →

Who can join

Adults 3 to 79, any sex, with General Population. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The probiotic strain Bacillus subtilis CU1 primes antimicrobial innate immune response and reduces low-grade inflammation: a clinical study.
Mourey F, Scholtens P, Jeanne JF, Rodriguez B, et al · · 2024 · cited 1× · PMID 39151920 · DOI 10.1163/18762891-bja00028

Verify or expand the search:

Other recruiting trials for General Population

Currently open trials in the same condition.

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NCT05758961 — Le French Gut: Characterization of Gut Microbiota Profiles in France · recruiting
NCT05328856 — Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being · NA · recruiting

Other Lesaffre International trials

Trials by the same sponsor.

NCT07431203 — Relationship Between Skin Microbiome, Epigenetic Age, and Facial Features in Aging · completed
NCT05699473 — Bioavailability Study of Folate in Healthy Subjects · NA · terminated
NCT03574844 — Effect of Oral Probiotic Yeast on the Composition of the Vaginal Microbiota in Healthy Women · NA · completed
NCT03150212 — Effect of Saccharomyces Cerevisiae on the Improvement of Gastro-intestinal Disorders Associated to IBS With C Phenotype · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05403398 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lesaffre International
Last refreshed: 8 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05403398.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing