A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating.
OBJECTIVE
To evaluate the effects of a combination probiotic on symptoms and colonic transit in patients with irritable bowel syndrome (IBS) and significant bloating.


METHODS
Forty-eight patients with Rome II IBS were randomized in a parallel group, double-blind design to placebo or VSL# 3 twice daily (31 patients received 4 weeks and 17 patients 8 weeks of treatment). Pre- and post-treatment colonic transit measurements were performed using scintigraphy with (111)In charcoal. Symptoms were summarized as an average daily score for the entire period of treatment and separately for the first 4 weeks of treatment. Weekly satisfactory relief of abdominal bloating was assessed.


RESULTS
Treatment with VSL# 3 was associated with reduced flatulence over the entire treatment period (placebo 39.5 +/- 2.6 vs VSL# 3 29.7 +/- 2.6, P = 0.011); similarly, during the first 4 weeks of treatment, flatulence scores were reduced (placebo 40.1 +/- 2.5 vs VSL# 3 30.8 +/- 2.5, P = 0.014). Proportions of responders for satisfactory relief of bloating, stool-related symptoms, abdominal pain and bloating scores were not different. Colonic transit was retarded with VSL# 3 relative to placebo (colon geometric center 2.27 +/- 0.20 vs 2.83 +/- 0.19, P = 0.05 respectively).


CONCLUSIONS
VSL# 3 reduces flatulence scores and retards colonic transit without altering bowel function in patients with IBS and bloating.
Kim
H J
HJ
Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Group, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.
Vazquez Roque
M I
MI
Camilleri
M
M
Stephens
D
D
Burton
D D
DD
Baxter
K
K
Thomforde
G
G
Zinsmeister
A R
AR
D000328:Adult; D000368:Aged; D004032:Diet; D019587:Dietary Supplements; D004108:Dilatation, Pathologic / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D013271:Gastric Dilatation / Q000503:physiopathology; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain; D018579:Patient Selection; D010919:Placebos; D019936:Probiotics / Q000627:therapeutic use*
D010919:Placebos