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

• Published in: PloS one 2023-02, Vol.18 (2), p.e0281817-e0281817
• Main Authors: Park, Min Young, Park, Soo-Yeon, Hartog, Anita, van Hoffen, Els, Kardinaal, Alwine, Kim, Joohee, Choi, Hee Jung, Kwon, Oran, Kim, Ji Yeon
• Format: Article
• Language: English
• Subjects: Analysis; Antibodies; Bacteria; Biology and Life Sciences; Cholera; Cholera - prevention & control; Cholera toxin; Cholera Vaccines; Clinical trials; Control; Diet; Digestive system; Digestive tract; Double-Blind Method; Evaluation; Food; Food cans; Gastrointestinal system; Gastrointestinal tract; Gram-positive bacteria; Humans; Identification and classification; Immune response; Immune system; Immunoglobulins; Immunomodulation; Inflammation; Inflammation - drug therapy; Inflammatory response; Informed consent; Intervention; Lactobacillus plantarum; Male; Medical research; Medicine and Health Sciences; Medicine, Experimental; Modulation; Placebos; Prevention; Probiotics; Proteins; Risk factors; Stimulation; Study Protocol; Substance abuse treatment; Toxins; Vaccination; Vaccines; Waterborne diseases
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0281817

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. Trial registration: * This trial is registered in the International Clinical Trials Registry Platform of WHO (ICTRP, registration number: KCT0002589).