[Treatment of chronic constipation with physiologic Escherichia coli bacteria. Results of a clinical study of the effectiveness and tolerance of microbiological therapy with the E. coli Nissle 1917 strain (Mutaflor)].
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
The E. coli preparation proved to be successful in the therapy of the idiopathic chronic constipation almost free of side effects.
Möllenbrink
M
M
Zentrum für Arbeitsmedizin, Menden.
Bruckschen
E
E
D000328:Adult; D002908:Chronic Disease; D003248:Constipation / Q000628:therapy*; D004311:Double-Blind Method; D004926:Escherichia coli; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000382:microbiology; D007792:Lactulose / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged
D007792:Lactulose
Behandlung der chronischen Obstipation mit physiologischen Escherichia-coli-Bakterien. Ergebnisse einer klinischen Studie zur Wirksamkeit und Verträglichkeit der mikrobiologischen Therapie mit dem E.-coli-Stamm Nissle 1917 (Mutaflor).