Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial.
OBJECTIVE
We have recently documented the efficacy of a highly concentrated probiotic preparation (VSL#3) in the prevention of flare-up in patients with chronic pouchitis. The aim of this study was to compare probiotic therapy with VSL#3 versus placebo in the ability to prevent the onset of acute pouchitis during the first year after ileal pouch-anal anastomosis.


METHODS
Forty consecutive patients who underwent ileal pouch-anal anastomosis for ulcerative colitis were randomized to receive either VSL#3 (1 packet containing 900 billion bacteria/day) (n = 20) or an identical placebo (n = 20) immediately after ileostomy closure for 1 year. The patients were assessed clinically, endoscopically, and histologically after 1, 3, 6, 9, and 12 months. Health-related quality of life was assessed using the Inflammatory Bowel Disease Questionnaire.


RESULTS
Two of the 20 patients (10%) treated with VSL#3 had an episode of acute pouchitis compared with 8 of the 20 patients (40%) treated with placebo (log-rank test, z = 2.273; P < 0.05). Treatment with VSL#3 determined a significant improvement in Inflammatory Bowel Disease Questionnaire score, whereas this was not the case with placebo.


CONCLUSIONS
Treatment with VSL#3 is effective in the prevention of the onset of acute pouchitis and improves quality of life of patients with ileal pouch-anal anastomosis.
Gionchetti
Paolo
P
Department of Internal Medicine, University of Bologna, Italy. paolo@med.unibo.it
Rizzello
Fernando
F
Helwig
Ulf
U
Venturi
Alessandro
A
Lammers
Karen Manon
KM
Brigidi
Patrizia
P
Vitali
Beatrice
B
Poggioli
Gilberto
G
Miglioli
Mario
M
Campieri
Massimo
M
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D003093:Colitis, Ulcerative / Q000601:surgery*; D003672:Defecation; D004311:Double-Blind Method; D004755:Enterobacteriaceae; D005260:Female; D006801:Humans; D007422:Intestines / Q000382:microbiology; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011183:Postoperative Complications / Q000188:drug therapy / Q000517:prevention & control; D019449:Pouchitis / Q000188:drug therapy* / Q000517:prevention & control*; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D016896:Treatment Outcome