Clinical trial: the effects of a probiotic mixture on non‐steroidal anti‐inflammatory drug enteropathy – a randomized, double‐blind, cross‐over, placebo‐controlled study

• Published in: Alimentary pharmacology & therapeutics Vol. 32; no. 2; pp. 209 - 214
• Main Authors: Montalto, M., Gallo, A., Curigliano, V., D’Onofrio, F., Santoro, L., Covino, M., Dalvai, S., Gasbarrini, A., Gasbarrini, G.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.07.2010; Blackwell
• Subjects: Adult; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Biological and medical sciences; Clinical trials; Cross-Over Studies; Digestive system; Double-Blind Method; Feces - chemistry; Female; Gastroenteritis - chemically induced; Gastroenteritis - prevention & control; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Indomethacin; Indomethacin - adverse effects; Inflammation; Intestine; Leukocyte L1 Antigen Complex - metabolism; Male; Medical sciences; Middle Aged; Nonsteroidal antiinflammatory drugs; Pharmacology. Drug treatments; probiotics; Probiotics - therapeutic use; Side effects; Non steroidal antiinflammatory agent; Human; Probiotic; Randomization; Health food; Placebo; Double blind study; Clinical trial; Mixture
• ISSN: 0269-2813; 1365-2036; 1365-2036
• DOI: 10.1111/j.1365-2036.2010.04324.x

Aliment Pharmacol Ther 2010; 32: 209–214 Summary Background  Non‐steroidal anti‐inflammatory drugs (NSAIDs) can cause serious gastrointestinal side effects. Faecal calprotectin assay represents a simple and practical method for diagnosis of NSAID enteropathy. Intestinal micro‐organisms are necessary for the development of NSAID‐induced small bowel lesions and hence it has been suggested that probiotics could protect against NSAID enteropathy. Aim  To evaluate the effect of a probiotic mixture in comparison with placebo on faecal 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 day 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 from day 15 to day 21. Results  During dosing with probiotic, median FCCs were significantly increased only at day 17 with respect to T0 values, whereas during dosing with placebo, they were significantly increased at every day from day 17 to day 21 with respect to T0 values. Conclusions  Treatment with VSL#3 before and during indomethacin therapy significantly reduces FCCs in healthy subjects with respect to placebo, suggesting that this approach could be useful in decreasing indomethacin‐induced intestinal inflammation.