Aim: A randomized, double-blind clinical trial including a change-over of medication was carried out for 9 weeks to investigate the efficacy of an E. coli preparation. The study's main objective was to prove that patients of the verum group had 1.5 stools/week more than placebo patients after a therapeutic period of just 4 weeks. Stool consistency as well as efficacy and compatibility of the medication as judged by doctor and patient were additional criteria.
Patients and method: For a 7-day run-in phase 134 patients were recruited who had suffered from constipation for 18.8 years in average. In this initial phase 64 patients evacuated more than 2 stools per week and were excluded from the study. The remaining 70 patients entered the therapeutic phase being randomly distributed amongst verum and placebo medication. After 4 weeks of therapy patients who delivered 2 or less stools/week obtained the alternative medication (change-over).
Results: Within the 4th week of therapy the average number of stools per week from patients treated with the E. coli preparation (4.9) was already significantly higher than from placebo-treated patients (2.6; p < 0.001). At the end of the 8th week of therapy the number of stools/week rose to 6.0 for verum-treated patients, whereas for the placebo-treated control group a decrease in stool frequency was observed (1.9 stools/week). The results of change-over patients confirmed the data of the therapy weeks 1 to 4.
Conclusion: The E. coli preparation proved to be successful in the therapy of the idiopathic chronic constipation almost free of side effects.