Impact of adding prophylactic probiotics to a bundle of standard preventative measures for Clostridium difficile infections: enhanced and sustained decrease in the incidence and severity of infection at a community hospital

Abstract

Background:

In 2003, hospitals in Quebec, Canada experienced an increase of NAP1/027 Clostridium difficile infections following antibiotic administration (CDIAA). At Pierre-Le Gardeur Hospital (PLGH), the incidence increased from 10 to over 25 cases per 1000 patient admissions.

Methods:

We report a quasi-experimental, prospective cohort study evaluating the effect on CDIAA of a probiotic added to existing C. difficile infection (CDI) standard preventative measures (SPM) in 31,832 hospitalized patients receiving antibiotics. Phase I (1580) measured the impact of SPM alone. In Phase II, 50 to 60 × 10⁹ cfu daily dose of oral Lactobacillus acidophilus CL1285 and L. casei LBC80R probiotic formula (Bio-K+) was administered to all patients receiving antibiotics. Phase III included the same intervention after a move to a new hospital facility. Phases II and III included 4968 patients. During Phase IV, 25,284 patients were submitted to the same regimen but outcome data were compared to those of similar hospitals in Quebec.

Results:

At the end of Phase III, CDIAA had decreased from more than 18 cases per 1000 patient admissions in Phase I to less than 5 cases. Reductions of CDI cases (73%) (p < 0.001) and severe CDI cases (76.4%) (p < 0.001) were observed. CDI recurrence rate was reduced by 39% (p < 0.001). During the following 6 years, the CDI rate averaged 2.71 cases per 10,000 patient-days at PLGH compared to 8.50 cases per 10,000 patient-days in equivalent hospitals located in Quebec.

Study limitation:

This study is not a randomized clinical trial; it is an open prospective study and should be treated as such. Also, following Phase II, PLGH moved into a new facility and this could have contributed to lower CDI.

Conclusions:

Specific probiotic product added to SPM and antibiotic stewardship activities resulted in a further reduction in CDI rates and was shown to be safe.

Key words::

• Antibiotic
• Clostridium difficile infection
• Lactobacillus acidophilus CL1285
• Lactobacillus casei LBC80R
• Probiotic
• Quasi-experimental design

Transparency

Declaration of funding

PLGH incurred all costs of this study, including those of the probiotic product. This study was exclusively set up and controlled by the Infection Control Committee of PLGH.

Declaration of financial/other relationships

B.C., E.J.C.G., and P.-J.M. are members of the Bio-K Plus International Inc. Infectious Disease Advisory Board and have received compensation for attending Advisory Board meetings on a yearly basis. J.A.A. and P.P. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors acknowledge Dr. Linda Dresser and Dr. Stuart Johnson for their participation in reviewing the manuscript. We particularly thank Dr. Curtis Donskey, Dr. Lynne V. McFarland, and Dr. William Trick for their most generous participation in criticizing and reviewing the manuscript. They are members of the Bio-K Plus International Inc. Infectious Disease Advisory Board and have received compensation for attending Advisory Board meetings on a yearly basis. We also acknowledge Mrs. Line Méthot BPharma MSc Admin for her participation in the conduct of the study.

Notes

*Bio-K+ is a registered trade name of Bio-K Plus International Inc., Laval, Quebec, Canada

^†Bio-K+ is a registered trade name of Bio-K Plus International Inc., Laval, Quebec, Canada