| Summary: | The use of probiotics in gastrointestinal ailments has shown therapeutic effects. The imbalance of the microbiota caused by antibiotic treatment or others has been shown to be restored to normal with probiotic treatment. In this study, a genomically and phenotypically safe probiotic Alkalihalobacillus clausii 088AE has been evaluated for ameliorating antibiotic-associated diarrhea (AAD) in pediatrics (PE, n = 60, 2–10 years), adolescent and adults (AA, n = 60, 11–65 years) through a randomized controlled clinical trial. A. clausii 088AE was administered for seven days (PE, 4 and AA, 6 billion/day) and primary and secondary endpoints were evaluated on different visits. Compared to the respective placebo arms, A. clausii 088AE improved the diarrheal (time to last unformed stool and diarrheal frequency) conditions in children, adolescents and adults. A. clausii 088AE treatment decreased AAD-severity score on visit 5 in both pediatric (0.12 ± 0.33, 12.39 folds), adult and adolescent (0.54 ± 0.36, 2.34 folds) groups compared to those respective placebo arm (p < 0.05). A. clausii 088AE was well tolerated, did not cause significant changes in vital and clinical safety parameters and subjects reported no adverse effects or serious adverse reactions. A. clausii 088AE is safe and therapeutically effective against AAD, reducing onset of diarrhea and related severity symptoms including abdominal discomfort and pain, bloating and flatulence. A. clausii 088AE may be recommended as a live bio-therapeutic agent for improving clinical pathophysiology of gastrointestinal ailments, in particular antibiotic-associated diarrhea and related symptoms.
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