The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active ulcerative colitis.
OBJECTIVE
Probiotics can maintain ulcerative colitis (UC) in remission effectively, but little is known of their ability to induce remission. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of a high-potency probiotic, VSL#3, for the treatment of mild-to-moderately active UC.


METHODS
Adult patients with mild-to-moderate UC were assigned randomly to groups that were given 3.6 x 10(12) CFU VSL#3 (n = 77) or placebo (n = 70), twice daily for 12 weeks. The primary end point was a 50% decrease in the Ulcerative Colitis Disease Activity Index (UCDAI) at 6 weeks. The secondary end points included remission by 12 weeks and reduction in total individual UCDAI parameters from baseline at 12 weeks. Intention-to-treat analysis was performed.


RESULTS
At week 6, the percentage of patients with an improvement in UCDAI score that was greater than 50% was significantly higher in the group given VSL#3 (25; 32.5%) than the group given placebo (7; 10%) (P = .001). At week 12, there were 33 patients given VSL#3 (42.9%) who achieved remission, compared with 11 patients given placebo (15.7%) (P < .001). Furthermore, significantly more patients given VSL#3 (40; 51.9%) achieved a decrease in their UCDAI that was greater than 3 points, compared with those given placebo (13; 18.6%) (P < .001). The VSL#3 group had significantly greater decreases in UCDAI scores and individual symptoms at weeks 6 and 12, compared with the placebo group.


CONCLUSIONS
VSL#3 is safe and effective in achieving clinical responses and remissions in patients with mild-to-moderately active UC.
Sood
Ajit
A
Department of Gastroenterology and Medicine, Dayanand Medical College and Hospital, Ludhiana, India.
Midha
Vandana
V
Makharia
Govind K
GK
Ahuja
Vineet
V
Singal
Dinesh
D
Goswami
Pooja
P
Tandon
Rakesh K
RK
D000328:Adult; D003093:Colitis, Ulcerative / Q000473:pathology* / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index
D007155:Immunologic Factors; D010919:Placebos