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Synbiotics and probiotics in the critically ill after the PROPATRIA trial

Morrow, Lee E.a,b,c; Gogineni, Vijayab; Malesker, Mark A.b,c

Current Opinion in Clinical Nutrition & Metabolic Care: March 2012 - Volume 15 - Issue 2 - p 147–150
doi: 10.1097/MCO.0b013e32834fcea8
NUTRITION AND THE INTENSIVE CARE UNIT: Edited by Mette Berger and Jeffrey I Mechanick

Purpose of review Recent clinical trials have furthered our understanding of the role of probiotic and synbiotic therapy across a variety of diverse diseases including antibiotic-associated diarrhea, Clostridium difficile associated diarrhea, acute pancreatitis, ventilator-associated pneumonia, and sepsis among others. Although each of these conditions has implications for critically ill patients, relatively few studies have specifically studied this vulnerable population.

Recent findings One recent clinical trial studying probiotics in severe pancreatitis (the PROPATRIA trial) found an unexpected increase in mortality in probiotic-treated patients. These results stimulated an immediate, extensive, and badly overdue discussion focused on the need for improved safety monitoring during the execution of all clinical trials using probiotics. However, issues with the design, execution, and analysis of PROPATRIA ultimately created more questions than it answered.

Summary Regardless of technical issues with the study, the increased mortality seen with probiotics cannot be ignored. As a result, various regulatory agencies have clarified their stance on the safety of probiotic research and the legacy of PROPATRIA is increasingly stringent regulation of this fledgling niche.

aDivision of Pulmonary, Critical Care and Sleep Medicine, Nebraska and Western Iowa Veterans’ Affairs Hospital

bCreighton University Medical Center

cSchool of Pharmacy and Health Professions, Creighton University, Omaha, Nebraska, USA

Correspondence to Lee E. Morrow, Creighton University Medical Center, 601 North 30th Street, Suite #3820, Omaha, NE 68131, USA. Tel: +1 402 449 4486; e-mail:

© 2012 Lippincott Williams & Wilkins, Inc.