Begtrup, Luise Mølenberg3; de Muckadell, Ove B Schaffalitzky4; Kjeldsen, Jens4; Christensen, René dePont3; Jarbøl, Dorte Ejg3
1 Research Unit of General Practice, Department of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU2 Medical Gastroenterology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU3 Research Unit of General Practice, Department of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU4 Medical Gastroenterology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU
OBJECTIVE. Meta-analyses have indicated effect of probiotics on irritable bowel syndrome (IBS). However, few long-term trials have been conducted and uncertainty remains as to effectiveness and long-term effect in a primary care setting. We aimed to investigate the effect of probiotics compared with placebo in the management of IBS in primary care during a 6-month treatment period and with a 6-month follow-up. MATERIAL AND METHODS. We randomized IBS patients fulfilling Rome III criteria to receive two capsules twice daily either containing placebo or a probiotic mixture of Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12 in an amount of 1.3 × 10(10) CFU per capsule. Primary endpoint was proportion of responders defined as patients reporting adequate relief (AR) at least 50% of the time in the 6-month treatment period. Secondary outcomes were proportions of patients reporting AR at different time points, and change in gastrointestinal symptoms and health-related quality of life (HrQOL) from baseline to 6 and 12 months. RESULTS. A total of 131 patients were included in this study. The proportion of responders in the treatment period was 52% (35/67) in the probiotic group versus 41% (26/64) in the placebo group, p = 0.18. Overall we found no difference between the groups in change in gastrointestinal symptoms after treatment. Patients improved in HrQOL, but with no statistically significant difference between the groups. CONCLUSION. During a 6-month treatment period, we were not able to detect a positive effect of probiotic when compared with placebo.
Scandinavian Journal of Gastroenterology. Supplement, 2013, Vol 48, Issue 10, p. 1127-35