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

Enck P, Zimmermann K, Menke G, Klosterhalfen S
Internal Medicine VI, University Medical Hospital, Tübingen

Abstract

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 prescribed the compound Symbioflor(R)-2 (Symbiopharm GmbH, Herborn, Germany), an Escherichia coli product (N=148), or placebo (n=150) for 8 weeks 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

Therapy 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.