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.
Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.
Rodrigo
R
Bibiloni
Richard N
RN
Fedorak
Gerald W
GW
Tannock
Karen L
KL
Madsen
Paolo
P
Gionchetti
Massimo
M
Campieri
Claudio
C
De Simone
R Balfour
RB
Sartor
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