THE EFFECTS OF A PROBIOTIC MIXTURE ON NSAID ENTEROPATHY: A RANDOMIZED, DOUBLE-BLIND, CROSS-OVER, PLACEBO-CONTROLLED STUDY.
Résumé
Background. Non-steroidal anti-inflammatory drugs (NSAIDs) can cause serious side gastrointestinal effects. Fecal calprotectin assay represents a simple and practical method for diagnosis of NSAID enteropathy. Intestinal microorganisms are necessary for the development of NSAID-induced small bowel lesions, so it has been suggested that probiotics could protect against NSAID enteropathy. Aim. To evaluate the effect of a probiotic mixture in respect to placebo on fecal calprotectin concentrations (FCCs) in healthy volunteers receiving indomethacin. Methods. In a double-blind, cross-over trial, 20 healthy volunteers ingested a daily dose of probiotic mixture (VSL#3) or placebo for 21 days. From day 16 to 19 all subjects were also administered 50 mg/day of indomethacin. FCCs were measured the day before starting probiotic/placebo ingestion (T0), and every day within the day 15 and 21. Results. During dosing with probiotic, median FCCs were significantly increased only at day 17 in respect to T0 values, while during dosing with placebo they were significantly increased at every day from day 17 to day 21 in respect to T0 values. Conclusions. Treatment with VSL#3 before and during indomethacin therapy significantly reduces FCCs in healthy subjects in respect to placebo, suggesting that this approach could be useful in decreasing indomethacin-induced intestinal inflammation.
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