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Probiotic regimen not protective against antibiotic-associated diarrhea in older patients
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A regimen of lactobacilli and bifidobacteria was no better than placebo in preventing antibiotic- and Clostridium difficile-associated diarrhea among older patients in a recent study.
In a multicenter, double blind efficacy trial, researchers randomly assigned 1,470 patients to a lyophilized powder containing lactobacilli and bifidobacteria and 1,471 to oral placebo once daily for 21 days. All participants were aged 65 years or older and had received or were about to receive treatment with at least one oral or parenteral antibiotic, with follow-up for 8 weeks.
Stephen J. Allen
“This is one of a very few large trials of a so-called ‘probiotic’ for a specific health indication,” researcher Stephen J. Allen, MD, professor of pediatrics and international health at the College of Medicine at Swansea University in the United Kingdom, told Healio.com. “Despite the encouraging evidence from smaller trials, we found no evidence that the microbial preparation resulted in a health benefit.”
Antibiotic-associated diarrhea (AAD), including cases of C. difficile-associated diarrhea (CDD), occurred similarly in the two groups (10.8% of treated patients vs. 10.4% of placebo recipients; RR=1.04; 95% CI, 0.84-1.28). CDD was the cause of AAD in 0.8% of treated cases and 1.2% of placebo patients (RR=0.71; 95% CI, 0.34-1.47).
During treatment, flatus was significantly more common in treated patients (12.5% vs. 10.2%; P=.045), as was the need for nasogastric tube in situ (0.5% vs. less than 0.1%; P=.019).
Serious adverse events, which were not attributed to study participation, occurred in 19.7% of the entire cohort and at similar rates in each group. Respiratory, thoracic and mediastinal disorders and GI and cardiac issues were reported most commonly.
“A high dose, multi-strain preparation of lactobacilli and bifidobacteria was not effective in preventing diarrhea, including C. diff diarrhea, among older inpatients taking antibiotics,” Allen said. “In addition, there was no evidence that the microbial preparation resulted in any other health benefits.”
Disclosure: Allen has been an invited guest at the Yakult Probiotic Symposium and received research funding from Yakult. He also received support from Cultech for research in probiotics.
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