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Intensive Care Med (1997) 23: 517-523 © Springer-Verlag 1997

ORIGINAL Saccharomyces boulardii prevents tubediarrhea in critically ill tube-fed patients* critically
A multicenter, randomized, double-blind placebo-controlled trial

G. Bleichner H. Bléhaut H. Mentec D. Moyse

Received: 5 August 1996 Accepted: 23 January 1997 * Study carried out with the "Diarrhea in tube-fed patients" studygroup,. see appendix. Supported by a grant from Laboratoire Biocodex, France

G. Bleichner () - H. Mentec Service de Réanimation Polyvalente. Centre Hospitalier Victor Dupouy, 69 rue du Lieutenant Colonel Prudhon, F-95100 Argenteuil, France FAX: +33 (1) 34 23 27 91 H. Bléhaut Laboratoire Biocodex, Chemin d'Armancourt, ZAC de Mercières, F-60200 Compiègne, France D. Moyse Lincoln System, 38 rueVauthier, F-92100 Boulogne Billancourt, France

Abstract 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 placebocontrolled study. Setting: Eleven intensive care units in teaching and general hospitals. Patients: Critically illpatients 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 perfeeding days from 18.9 to 14.2% [odds ratio (OR) = 0.67, 95% confidence interval (CI) = 0.500.90, 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). Conclusion: S. boulardii, prevents diarrhea in critically ill tube-fed patients, especially in patients with risk factors for diarrhea. Key words: Enteral feeding - Diarrhea - Intensive care

Introduction
Diarrhea is a common complication in critically ill tube-fed patients. Its frequency has been reported to be from 2.3 to 68% in patients receiving enteral nutrition [1-3]. Theconsequences of diarrhea may be clinically important: electrolyte losses, increased risk of nosocomial infections and pressure sores, and change to parenteral nutrition at greater risk and cost. Many factors have been reported to be associated with diarrhea in tube-fed patients. Some can be controlled by state-of-the-art management: sterile, ready-to-use diet;

administration; absence of lactose in thediet or drugs or elixir containing poorly absorbed sugars as sorbitol or mannitol [4, 5]. Others cannot be avoided, since they are associated with the patient's condition: hypoalbuminemia, sepsis or previous shock [6,7]. Some are due to treatment, especially antibiotics, which have been reported as the factor the most strongly associated with diarrhea during tube feeding [3]. Saccharomycesboulardii has been demonstrated to be effective in the prevention of antibiotic-associated diarrhea, in the treatment of diarrhea and colitis due to Clostridium difficile and in some other conditions [8, 9].

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518 Table 1 Diarrhea scorea
Consistency Formed Semi-solid Liquid < 200 1 3 5 Estimated volume (ml) 200-250 2...