Abstract:Objective Functional constipation is a chronic gastrointestinal disorder caused by multiple factors, with a relatively high and increasing prevalence in China. Previous studies have found that Bacillus coagulans (B. coagulans)CCFM1041 can alleviate symptoms of functional constipation in mice.Method A double-blind, randomized controlled clinical trial was conducted to evaluate the clinical efficacy of CCFM1041 in relieving functional constipation. A total of 73 participants were observed for changes in constipation-related indicators, serum levels of gastrointestinal regulatory neurotransmitters, and gut microbiota before and after the intervention.Result After taking CCFM1041, 84.2% of participants experienced increased bowel movement frequency, and 94.7% of participants showed improved stool consistency. Compared with the control group, CCFM1041 significantly raised the mass concentrations of motilin (MTL) and gastrin (GAS) in the serum and effectively regulated the gut microbiota. The correlation analysis indicates that CCFM1041 may exert the effect by modulating gut microbiota.Conclusion CCFM1041 can effectively alleviate symptoms of functional constipation in participants. The research results provide scientific evidence for the application of B. coagulans CCFM1041 in constipation relief and offer support for screening probiotics effective in alleviating constipation.