Sporulated Bacillus as alternative treatment for diarrhea of hospitalized adult patients under enteral nutrition: A pilot randomized controlled study.

BACKGROUND & AIMS: Among hospitalized patients receiving enteral nutrition (EN), malnutrition and antibiotic use are some of the most common causes of diarrhea. Prebiotics and probiotics agents have been used for treatment of diarrhea in such patients. The aim of this study was to assess the efficacy of a sporulated Bacillus strain (Bacillus cereus A 05), compared to a control group using a prebiotic (soluble fiber), in reducing diarrhea in patients receiving EN and antibiotic therapy.

METHODS: Patients with diarrhea receiving EN were randomized to receive either B. cereus (study group) or soluble fiber (control group) for five days. The group treated with B. cereus received 4 vials with 5 mL × 106 every 6 h. The control group treated with fiber received 10 g of soluble fiber every 8 h. Data assessed were serum albumin, nutrition status through Subjective Global Assessment (SGA), antibiotic use and osmolality (normal or hyperosmolar) of the tube feeding diets.

RESULTS: Twenty-nine patients were treated in each group. There was no significant difference between the groups regarding age, serum albumin, SGA score, dietary osmolality and antibiotic use. There was no significant difference between groups in ceasing diarrhea. However, the group treated with B. cereus took fewer days to cease diarrhea (2.5 ± 1.3 versus 3.7 ± 1.1 days, p = 0.011). Specifically, in the group treated with B. cereus A 05, malnourished patients did better than non-malnourished patients regarding diarrhea cessation (100% versus 25%, p < 0.001).

CONCLUSIONS: B. cereus A 05 was more effective than fiber in reducing diarrhea among patients under EN and antibiotic therapy and was more effective among malnourished patients.