Elsevier

Mayo Clinic Proceedings

Volume 76, Issue 9, September 2001, Pages 883-889
Mayo Clinic Proceedings

Original Article
Lack of Effect of Lactobacillus GG on Antibiotic-Associated Diarrhea: A Randomized, Placebo-Controlled Trial

https://doi.org/10.4065/76.9.883Get rights and content

Objectives

To assess the efficacy of Lactobacillus GG in preventing antibiotic-associated diarrhea (AAD) in adults and, secondarily, to assess the effect of coadministered Lactobacillus GG on the number of tests performed to determine the cause of diarrhea.

Patients and Methods

In this prospective, randomized, double-blind, placebo-controlled trial conducted from July 1998 to October 1999, 302 hospitalized patients receiving antibiotics were randomized to receive Lactobacillus GG, 20 × 109 CFU/d, or placebo for 14 days. Subjects recorded the number of stools and their consistency daily for 21 days. The primary outcome was the proportion of patients who developed diarrhea in the first 21 days after enrollment. Weekly telephone follow-up was also performed. Results were analyzed in an intention-to-treat fashion.

Results

Diarrhea developed in 39 (29.3%) of 133 patients randomized to receive Lactobacillus GG and in 40 (29.9%) of 134 patients randomized to receive placebo (P=.93). No additional difference in the rate of occurrence of diarrhea was found between treatment and placebo patients in a subgroup analysis of those treated with β-lactam vs non-β-lactam antibiotics. Too few patients had stool cultures, additional laboratory tests for diarrhea, or a positive diagnosis of Clostridium difficile infection to assess between-group differences.

Conclusion

Lactobacillus GG in a dose of 20 × 109 CFU/d did not reduce the rate of occurrence of diarrhea in this sample of 267 adult patients taking antibiotics initially administered in the hospital setting.

Section snippets

Study Population

This study was a prospective, randomized, double-blind, placebo-controlled trial. Patients were potentially eligible for the study if they were admitted to a general internal medicine inpatient service at Saint Marys Hospital, a 1157-bed tertiary care hospital in Rochester, Minn, from July 1, 1998, to October 31, 1999, and received an intravenous or oral antibacterial agent for a presumed or proved infection. Exclusion criteria included treatment with an antibiotic for more than 24 hours prior

Participant Flow and Follow-up

Patient flow is summarized in Figure 1, and baseline characteristics are summarized in Table 1.

Over the 16-month study period, 2967 patients were screened by the study nurse as potential candidates for this study. Of the 2967 patients screened, 2618 met 1 or more exclusion criteria, 47 did not wish to participate, and 302 met the inclusion criteria and agreed to participate. Of the 302 patients who consented to participate, 34 failed to complete the study, and 1 patient enrolled but

DISCUSSION

This study differs from previous studies of AAD in that it is a large, prospective, double-blind, placebo-controlled trial in adult patients with sufficient statistical power to detect a clinically significant effect of Lactobacillus GG in the prevention of AAD.

In this study, we found that coadministration of Lactobacillus GG at a dose of 20 x 109 CFU/d to hospitalized adults being treated with a variety of antimicrobial agents (β-lactam or non-β-lactam) was not effective in preventing AAD

CONCLUSION

Lactobacillus GG in a dose of 20 × 109 CFU/d did not reduce the rate of occurrence of AAD in this sample of 267 initially hospitalized adult patients prescribed antibiotics for a variety of infectious diseases. Further stratification by use of β-lactams at enrollment and compliance with study medication did not result in any significant differences. No difference was seen between the groups with respect to consistency or frequency of stools.

The study included too few patients with stool

REFERENCES (21)

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This study was supported in part by a grant from ConAgra Foods, Inc, Omaha, Neb.

1

Dr Corr is now with the Riverside Medical Clinic, Riverside, Calif.

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