VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis.
OBJECTIVE
Intestinal bacteria have been implicated in the initiation and perpetuation of IBD; in contrast, "probiotic bacteria" have properties possibly effective in treating and preventing relapse of IBD. We evaluated the safety and efficacy of VSL#3 and the components, and the composition of the biopsy-associated microbiota in patients with active mild to moderate ulcerative colitis (UC).


METHODS
Thirty-four ambulatory patients with active UC received open label VSL#3, 3,600 billion bacteria daily in two divided doses for 6 wk. The presence of biopsy-associated bacteria was detected using a nucleic acid-based method and the presence of VSL#3 species confirmed by DNA sequencing of 16S rRNA.


RESULTS
Thirty-two patients completed 6 wk of VSL#3 treatment and 2 patients did not have the final endoscopic assessment. Intent to treat analysis demonstrated remission (UCDAI < or = 2) in 53% (n = 18); response (decrease in UCDAI > or = 3, but final score > or =3) in 24% (n = 8); no response in 9% (n = 3); worsening in 9% (n = 3); and failure to complete the final sigmoidoscopy assessment in 5% (n = 2). There were no biochemical or clinical adverse events related to VSL#3. Two of the components of VSL#3 were detected by PCR/DGGE in biopsies collected from 3 patients in remission.


CONCLUSIONS
Treatment of patients with mild to moderate UC, not responding to conventional therapy, with VSL#3 resulted in a combined induction of remission/response rate of 77% with no adverse events. At least some of the bacterial species incorporated in the probiotic product reached the target site in amounts that could be detected.
Bibiloni
Rodrigo
R
Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.
Fedorak
Richard N
RN
Tannock
Gerald W
GW
Madsen
Karen L
KL
Gionchetti
Paolo
P
Campieri
Massimo
M
De Simone
Claudio
C
Sartor
R Balfour
RB
D000328:Adult; D003093:Colitis, Ulcerative / Q000382:microbiology / Q000628:therapy*; D004269:DNA, Bacterial / Q000032:analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D019233:Retreatment; D016896:Treatment Outcome
D004269:DNA, Bacterial