Saccharomyces boulardii prevents diarrhea in critically ill tube-fed patients. A multicenter, randomized, double-blind placebo-controlled trial.

OBJECTIVE

To assess the preventive effect of Saccharomyces boulardii on diarrhea in critically ill tube-fed patients and to evaluate risk factors for diarrhea.

DESIGN

Prospective, multicenter, randomized, double-blind placebo-controlled study.

SETTING

Eleven intensive care units in teaching and general hospitals.

PATIENTS

Critically ill patients whose need for enteral nutrition was expected to exceed 6 days.

INTERVENTION

S. boulardii 500 mg four times a day versus placebo.

MEASUREMENTS AND RESULTS

Diarrhea was defined by a semiquantitative score based on the volume and consistency of stools. A total of 128 patients were studied, 64 in each group. Treatment with S. boulardii reduced the mean percentage of days with diarrhea per feeding days from 18.9 to 14.2% [odds ratio (OR) = 0.67, 95% confidence interval (CI) = 0.50-0.90, P = 0.0069]. In the control group, nine risk factors were significantly associated with diarrhea: nonsterile administration of nutrients in open containers, previous suspension of oral feeding, malnutrition, hypoalbuminemia, sepsis syndrome, multiple organ failure, presence of an infection site, fever or hypothermia, and use of antibiotics. Five independent factors were associated with diarrhea in a multivariate analysis: fever or hypothermia, malnutrition, hypoalbuminemia, previous suspension of oral feeding, and presence of an infection site. After adjustment for these factors, the preventive effect of S. boulardii on diarrhea was even more significant (OR = 0.61, 95% CI = 0.44-0.84, P < 0.0023).

CONCLUSIONS

S. boulardii prevents diarrhea in critically ill tube-fed patients, especially in patients with risk factors for diarrhea.