The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active ulcerative colitis.
Level 2 - randomized trial
Multicenter, randomized, double-blind, placebo-controlled trial
PubMed 19631292 · doi:10.1016/j.cgh.2009.07.016
What was done
A multicenter, randomized, double-blind, placebo-controlled trial evaluated whether the probiotic preparation VSL#3 induces remission in adult patients with mild-to-moderately active ulcerative colitis. Participants were randomly assigned to receive VSL#3 at 3.6 × 10^12 CFU twice daily (n = 77) or placebo twice daily (n = 70) for 12 weeks. The primary endpoint was a ≥50% decrease in the Ulcerative Colitis Disease Activity Index (UCDAI) at 6 weeks. Secondary endpoints included remission at 12 weeks and reductions in individual and total UCDAI parameters, analyzed via intention-to-treat.
What was found
At week 6, significantly more patients in the VSL#3 group achieved a >50% improvement in UCDAI score compared with placebo (32.5% [25/77] vs. 10% [7/70]; P = .001). By week 12, remission was achieved in 42.9% (33/77) of the VSL#3 group versus 15.7% (11/70) of the placebo group (P < .001). Furthermore, a >3-point decrease in UCDAI occurred in 51.9% (40/77) of the VSL#3 group versus 18.6% (13/70) with placebo (P < .001). VSL#3 also produced significantly greater reductions in total UCDAI scores and individual symptom subscores at weeks 6 and 12.
Why it matters
While probiotics have primarily been studied for maintenance of quiescent ulcerative colitis, this trial provides randomized evidence that high-potency VSL#3 can actively induce clinical response and remission in mild-to-moderate disease.
Limits
The study had a modest sample size (n = 147) and a short follow-up duration of 12 weeks. The abstract does not report concurrent baseline medications, endoscopic mucosal healing details, or specific adverse event data. Results apply specifically to mild-to-moderate disease and the VSL#3 formulation and cannot be generalized to severe colitis or other probiotic strains.
Cited by
- supports Clinical and animal studies have reported therapeutic benefits of high-dose probiotic formulations (such as VSL#3 or Visbiome at 400 to 800 billion CFUs) for colitis and irritable bowel syndrome.