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. The changes of cholera toxin-specific antibody levels and local/systemic inflammatory responses will be evaluated in blood.

The level of fecal calprotectin, a marker of gut inflammation, will be the primary outcome. 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). Forty-six males aged 20 to 50 with healthy bowel habits will be randomly allocated to the placebo or intervention group. 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.

This study focuses on evaluating gut stimulation induced by the oral cholera vaccine in healthy people. This study aims to develop a safe human challenge model to study gastrointestinal inflammation and immune function. Dietary modulation is one of the factors that regulate the immune response in the gut. It is crucial for human health that the immune system of the gastrointestinal tract works effectively.

Change in bowel habits icd 10