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Article History

Received: 16 May 2025

Accepted: 23 March 2026

First Online: 7 April 2026

Declarations

:

: The study has been approved by the Danish Data Protection Agency (P-2022–356), and permission for human experiments and recruitment of participants has been obtained from the Scientific Ethics Committee for Copenhagen Regional Hospital before initiation and approved by the Danish Data Protection Agency (H-22014666). As probiotics are considered dietary supplements and not pharmaceuticals, no authorization by the Danish Medicines Agency is required. The study is performed in accordance with the requirements of the Revised Declaration of Helsinki. The study is registered at ClinicalTrials.gov (NCT05553652) before inclusion of the first participant. Consent for participation will be obtained from all participants, and participants can discontinue at any time point on their request. Sample materials are temporarily stored in a Research Biobank if there is a need for reanalysis or possibly additional analysis to collect data related to this project. The end date for the research biobank is 01.08.2032. No additional consent provisions are needed for the collection and use of participant data and biological specimens in this study.

: No personal data is published in this protocol article. Consent from participants is obtained/will be obtained to publish the data as anonymous data when the study is completed. The participant information and consent form are available as supplementary material in both Danish and English.

: AKSF is an employee of Chr. Hansen A/S, part of Novonesis Group, but will not be involved in the study conduct, data management or statistical analysis. The rest of the authors report no other conflicts of interest in this work.