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The Probiotic Preparation, VSL#3 Induces Remission in Patients With Mild-to-Moderately Active Ulcerative Colitis
- Source :
- Clinical Gastroenterology and Hepatology. 7:1202-1209.e1
- Publication Year :
- 2009
- Publisher :
- Elsevier BV, 2009.
-
Abstract
- 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.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.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.VSL#3 is safe and effective in achieving clinical responses and remissions in patients with mild-to-moderately active UC.
- Subjects :
- Adult
Male
medicine.medical_specialty
Placebo
Severity of Illness Index
Gastroenterology
law.invention
Placebos
Probiotic
Double-Blind Method
Randomized controlled trial
law
Internal medicine
Severity of illness
Clinical endpoint
Humans
Immunologic Factors
Medicine
Colitis
Intention-to-treat analysis
Hepatology
business.industry
Probiotics
Middle Aged
medicine.disease
Ulcerative colitis
Intention to Treat Analysis
Surgery
Colitis, Ulcerative
Female
business
Subjects
Details
- ISSN :
- 15423565
- Volume :
- 7
- Database :
- OpenAIRE
- Journal :
- Clinical Gastroenterology and Hepatology
- Accession number :
- edsair.doi.dedup.....c47a42d985a3dc78bfb4f55610dce293