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Probiotic combination reduces antibiotic-associated diarrhea and C. difficile in older adults

Original Internist, March, 2008 by Donald Brown

Reference: Hickson M, D'Souza A, Muthu N, et al. Use of probiotic Lactobacillus preparation to prevent diarrhea associated with antibiotics: randomized double blind placebo controlled trial. BMJ 2007;335:80; doi:10.1136/bmj.39231.599815.55 [Epub].

Design: Randomized, double-blind, placebo-controlled trial

Participants: 135 elderly inpatients (mean age 74 years old) who were prescribed antibiotics (single or multiple antibiotics, oral or intravenous)

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Study Medication and Dosage: A 100 g (97 ml) probiotic yogurt drink (Actimel, Danone, France) containing Lactobacillus casei DN-114 001 (1.0 x 108 cfu/ml), Streptococcus thermophilus (1.0 x [10.sup.8] cfu/ml), and Lactobacillus bulgaricus (1.0 x [10.sup.7] cfu/ml) b.i.d. The drink was consumed half an hour before or one to two hours after meals. The placebo group received commercial "milkshake" (Yazoo, Campina, Netherlands) that is free of probiotics.

Duration: Participants began using the drink within 48 hours of starting antibiotic therapy and continued doing so for one week after they stopped taking antibiotics.

Outcome Measures: The primary outcome was the occurrence of diarrhea. Diarrhea was defined as more than two liquid stools per day for three or more days in quantities in excess of normal for each patient. The secondary outcome was the occurrence of Clostridium difficile infection, defined as an episode of diarrhea combined with the detection of toxins A or B, or both, from a stool sample. A baseline stool sample was collected to screen for asymptomatic C. difficile infection. Bowel movements were monitored with stool charts, which were checked every day for accuracy. When there was evidence of diarrhea, a stool sample was analyzed for C. difficile toxin.

Key Findings: One hundred thirteen patients completed the study (probiotic group, n = 57). The most common reason for exclusion (61%) was the likelihood of diarrhea due to causes unrelated to antibiotics. Most patients received one antibiotic, but about 40% received two. In the probiotic group, 7 of 57 participants (12%) developed diarrhea compared to 19 of 56 (34%) in the placebo group (p = 0.007). The absolute risk reduction for occurrence of antibiotic associated diarrhea was 22% (95% confidence interval, 0.07 to 0.85). Data on possible C. difficile was available for only 109 patients. No one in the probiotic group had C. difficile infection compared to 9 of 53 (17%) in the placebo group (p = 0.001). There were no adverse events related to the study drinks.

Practice Implications: While antibiotic-associated diarrhea (AAD) is a risk factor across many age groups, diarrhea secondary to C. difficile infection (about 15-25% of all cases of AAD) is more common in the elderly, usually within two to three weeks after cessation of antibiotic therapy. Over the past couple of years, C. difficile outbreaks in both Canada and the Netherlands have been associated with significant mortality in elderly hospitalized patients. This clinical trial adds the use of a Lactobacillus and Streptococcus combination to the considerations for the prevention of both AAD and C. difficile in elderly patients. As noted in previous reviews in this column, the best data to date on the prevention of C. difficile has been with Saccharomyces boulardii (specifically the product Florastor), typically used at a dose of 1 g/day.

Author: Donald Brown, ND

Health Care Industry

Probiotic combination reduces antibiotic-associated diarrhea and C. difficile in older adults

Original Internist, March, 2008 by Donald Brown

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