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


OBJECTIVE
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.
Montalto
M
M
Institute of Internal Medicine, Catholic University, Rome, Italy. mmontalto@rm.unicatt.it
Gallo
A
A
Curigliano
V
V
D'Onofrio
F
F
Santoro
L
L
Covino
M
M
Dalvai
S
S
Gasbarrini
A
A
Gasbarrini
G
G
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005243:Feces / Q000737:chemistry*; D005260:Female; D005759:Gastroenteritis / Q000139:chemically induced* / Q000517:prevention & control; D006801:Humans; D007213:Indomethacin / Q000009:adverse effects*; D039841:Leukocyte L1 Antigen Complex / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D039841:Leukocyte L1 Antigen Complex; D007213:Indomethacin