Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial.
OBJECTIVE
Pouchitis is the major long-term complication after ileal pouch-anal anastomosis for ulcerative colitis. Most patients have relapsing disease, and no maintenance treatment study has been performed. We evaluated the efficacy of a probiotic preparation (VSL#3) containing 5 x 10(11) per gram of viable lyophilized bacteria of 4 strains of lactobacilli, 3 strains of bifidobacteria, and 1 strain of Streptococcus salivarius subsp. thermophilus compared with placebo in maintenance of remission of chronic pouchitis.


METHODS
Forty patients in clinical and endoscopic remission were randomized to receive either VSL#3, 6 g/day, or an identical placebo for 9 months. Patients were assessed clinically every month and endoscopically and histologically every 2 months or in the case of a relapse. Fecal samples were collected for stool culture before and after antibiotic treatment and each month during maintenance treatment.


RESULTS
Three patients (15%) in the VSL#3 group had relapses within the 9-month follow-up period, compared with 20 (100%) in the placebo group (P < 0.001). Fecal concentration of lactobacilli, bifidobacteria, and S. thermophilus increased significantly from baseline levels only in the VSL#3-treated group (P < 0.01).


CONCLUSIONS
These results suggest that oral administration of this new probiotic preparation is effective in preventing flare-ups of chronic pouchitis.
Gionchetti
P
P
Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy. paolo@med.unibo.it
Rizzello
F
F
Venturi
A
A
Brigidi
P
P
Matteuzzi
D
D
Bazzocchi
G
G
Poggioli
G
G
Miglioli
M
M
Campieri
M
M
D000284:Administration, Oral; D000328:Adult; D001644:Bifidobacterium; D002908:Chronic Disease; D004311:Double-Blind Method; D005243:Feces / Q000382:microbiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007422:Intestines / Q000382:microbiology*; D007778:Lactobacillus; D015993:Life Tables; D008297:Male; D019449:Pouchitis / Q000628:therapy*; D019936:Probiotics / Q000008:administration & dosage*; D012008:Recurrence; D013291:Streptococcus