Treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study.
OBJECTIVE
VSL#3 is a high-potency probiotic mixture that has been used successfully in the treatment of pouchitis. The primary end point of the study was to assess the effects of supplementation with VSL#3 in patients affected by relapsing ulcerative colitis (UC) who are already under treatment with 5-aminosalicylic acid (ASA) and/or immunosuppressants at stable doses.


METHODS
A total of 144 consecutive patients were randomly treated for 8 weeks with VSL#3 at a dose of 3,600 billion CFU/day (71 patients) or with placebo (73 patients).


RESULTS
In all, 65 patients in the VSL#3 group and 66 patients in the placebo group completed the study. The decrease in ulcerative colitis disease activity index (UCDAI) scores of 50% or more was higher in the VSL#3 group than in the placebo group (63.1 vs. 40.8; per protocol (PP) P=0.010, confidence interval (CI)₉₅(%) 0.51-0.74; intention to treat (ITT) P=0.031, CI₉₅(%) 0.47-0.69). Significant results with VSL#3 were recorded in an improvement of three points or more in the UCDAI score (60.5% vs. 41.4%; PP P=0.017, CI₉₅(%) 0.51-0.74; ITT P=0.046, CI₉₅(%) 0.47-0.69) and in rectal bleeding (PP P=0.014, CI₉₅(%) 0.46-0.70; ITT P=0.036, CI₉₅(%) 0.41-0.65), whereas stool frequency (PP P=0.202, CI₉₅(%) 0.39-0.63; ITT P=0.229, CI₉₅(%) 0.35-0.57), physician's rate of disease activity (PP P=0.088, CI₉₅(%) 0.34-0.58; ITT P=0.168, CI₉₅(%) 0.31-0.53), and endoscopic scores (PP P=0.086, CI₉₅(%) 0.74-0.92; ITT P=0.366, CI₉₅(%) 0.66-0.86) did not show statistical differences. Remission was higher in the VSL#3 group than in the placebo group (47.7% vs. 32.4%; PP P=0.069, CI₉₅(%) 0.36-0.60; ITT P=0.132, CI₉₅(%) 0.33-0.56). Eight patients on VSL#3 (11.2%) and nine patients on placebo (12.3%) reported mild side effects.


CONCLUSIONS
VSL#3 supplementation is safe and able to reduce UCDAI scores in patients affected by relapsing mild-to-moderate UC who are under treatment with 5-ASA and/or immunosuppressants. Moreover, VSL#3 improves rectal bleeding and seems to reinduce remission in relapsing UC patients after 8 weeks of treatment, although these parameters do not reach statistical significance.
Tursi
Antonio
A
"Lorenzo Bonomo" Hospital, Andria, Italy. antotursi@tiscali.it
Brandimarte
Giovanni
G
Papa
Alfredo
A
Giglio
Andrea
A
Elisei
Walter
W
Giorgetti
Gian Marco
GM
Forti
Giacomo
G
Morini
Sergio
S
Hassan
Cesare
C
Pistoia
Maria Antonietta
MA
Modeo
Maria Ester
ME
Rodino'
Stefano
S
D'Amico
Teresa
T
Sebkova
Ladislava
L
Sacca'
Natale
N
Di Giulio
Emilio
E
Luzza
Francesco
F
Imeneo
Maria
M
Larussa
Tiziana
T
Di Rosa
Salvatore
S
Annese
Vito
V
Danese
Silvio
S
Gasbarrini
Antonio
A
D000328:Adult; D001379:Azathioprine / Q000008:administration & dosage / Q000627:therapeutic use*; D001644:Bifidobacterium; D003093:Colitis, Ulcerative / Q000628:therapy*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007778:Lactobacillus; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D018579:Patient Selection; D019936:Probiotics / Q000008:administration & dosage / Q000627:therapeutic use*; D012008:Recurrence; D012074:Remission Induction; D012720:Severity of Illness Index; D048249:Streptococcus thermophilus; D016896:Treatment Outcome
D019804:Mesalamine; D001379:Azathioprine