Abstract

Introduction: Probiotics have been promoted as an adjunct in preventing or minimizing infection as well as attenuating the inflammatory response. Lactobacillus GG, a non pathogenic organism is reputed to replenish healthy gut flora and may decrease diarrhea and risk for infection during critical illness.. Hypothesis: This study was designed to evaluate the efficacy of an enterally administered probiotic agent (Lactobacillus GG) in curtailing diarrhea and infection in the ICU. Methods: Setting: 56 Bed SICU in a 805 Bed Urban teaching Hospital Design: Prospective, randomized, double masked controlled trial. Subjects received Lactobacillus GG or placebo within 72 hours of the onset of diarrhea or C. difficile positive culture. Supplements were administered orally or per feeding tube. Study endpoint was hospital discharge. Parameters measured included resolution of diarrhea, APACHE II scores, gender, age, presence of mechanical ventilation, BAL cultures, surgical site infection, blood,urine or catheter infection. Secondary measures included mean ventilator days (MVD), ICU Length Of Stay(LOS) and hospital LOS. Results: There were 69 enrolled subjects for which complete data was available. Lactobaccillus (LGG) study group had 36(52.2 %) vs. Placebo (PLC) 33 (47.8 %) patients. There were 28 female vs. 41male subjects enrolled. Mean subject age was 60. Mean APACHE II score was 16.7. The resolution of diarrhea was difficult to quantify and hence not reported here. Subjects with Apache scores of less than 20 numbered 33 with 15 receiving LGG. The subjects LOS was 21 days in PLC vs 18 days in the LGG group. The MVD was 9 in the LGG group vs 17 days in the PLC group. Conclusions: Probiotic supplementation appeared to have a modest effect on subject LOS and MVD in patients with Apache scores less than 20. We were not able to meet our study target of 180 patients to achieve statistical significance. A larger multi center trial is necessary to accrue adequate numbers in order to validate our study.

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