Randomized Controlled Treatment Trial of Irritable Bowel Syndrome with a Probiotic E.-coli Preparation (DSM17252) Compared to Placebo

Background: Therapy trials with bacterial compounds in irritable bowel syndrome (IBS) have produced conflicting results and, so far, an E.-coli preparation has not been used. Methods: Two hundred and ninety-eight patients with lower abdominal symptoms diagnosed as IBS were treated for 8 weeks by the compound Symbioflor (R)-2(Symbiopharm GmbH, Herborn, Germany), an Escherichia coli product (N = 148), or placebo (n = 150) in a double-blinded, randomized fashion. Patients were seen weekly by the physician, who assessed the presence of core IBS symptoms. Both an abdominal pain score (APS) as well as a general symptom score (GSS) were used as primary endpoints. Responders had to have complete absence of IBS core symptoms at : >= 1 visit during treatment. Results: The responder rate in GSS to the drug was 27/148 (18.2%) in comparison to placebo with 7/150 (4.67%) (p = 0.000397). The improvement in APS was 28/148 (18.9%) and 10/150 (6.67%) for placebo (p=0.001649). The response was reached from visit 3 onwards with both medication and placebo. Post-hoc analysis revealed no significant differences in efficacy of the drug between the gender and different age groups. Conclusion: Treatment of IBS with the probiotic Symbioflor-2 is effective and superior to placebo in reducing typical symptoms of IBS patients seen by general practitioners and by gastroenterologists.