Study protocol for cholera vaccination as a model to measure the inflammatory response in the gut: A case of modulation with a Lactobacillus plantarum K8 lysate

Min Young Park, Soo Yeon Park, Anita Hartog, Els van Hoffen, Alwine Kardinaal, Joohee Kim, Hee Jung Choi, Oran Kwon, Ji Yeon Kim

Research output: Contribution to journalArticlepeer-review

Abstract

It is crucial for human health that the immune system of the gastrointestinal tract works effectively. Dietary modulation is one of the factors that regulate the immune response in the gut. This study aims to develop a safe human challenge model to study gastrointestinal inflammation and immune function. This study focuses on evaluating gut stimulation induced by the oral cholera vaccine in healthy people. In addition, this paper describes the study design for assessing the efficacy and safety of a probiotic lysate, identifying whether functional ingredients in food can modulate inflammatory response induced by oral cholera vaccine. Forty-six males aged 20 to 50 with healthy bowel habits will be randomly allocated to the placebo or intervention group. Participants will consume 1 capsule of probiotic lysate or placebo twice daily for 6 weeks, take oral cholera vaccines on visit 2 (day 15) and visit 5 (day 29). The level of fecal calprotectin, a marker of gut inflammation, will be the primary outcome. The changes of cholera toxin-specific antibody levels and local/systemic inflammatory responses will be evaluated in blood. The purpose of this study is to evaluate gut stimulation of the oral cholera vaccine and investigate the effect of a probiotic lysate on improving the mild inflammatory response induced by the vaccine or supporting the immune response in healthy subjects.

Original languageEnglish
Article numbere0281817
JournalPLoS ONE
Volume18
Issue number2 February
DOIs
StatePublished - Feb 2023

Bibliographical note

Publisher Copyright:
© 2023 Park et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Fingerprint

Dive into the research topics of 'Study protocol for cholera vaccination as a model to measure the inflammatory response in the gut: A case of modulation with a Lactobacillus plantarum K8 lysate'. Together they form a unique fingerprint.

Cite this