A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial.
BACKGROUND
In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul(®)) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture.


METHODS
This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation).


RESULTS
Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected.


CONCLUSIONS
Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.
Gastrointestinal Unit, Department of Medicine and Surgery, University of Salerno, Via S Allende, 84081, Baronissi, Salerno, Italy.
C
C
Bucci
F
F
Tremolaterra
S
S
Gallotta
A
A
Fortunato
C
C
Cappello
C
C
Ciacci
P
P
Iovino
D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005414:Flatulence / Q000628:therapy*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult