Fedorak.qxp 18/4/08 09:45 Page 44
Probiotics
Table 1: Clinical Trials of Probiotics in Irritable Bowel Syndrome
1st Author n Duration (months) Probiotic Clinical Score p
Maupas
61
34 1 S. boulardii Improved stool number and consistency <0.05
Halpern
62
18 4 L. acidophilus Improved symptoms 0.01
Nobaek
63
60 1 L. plantarum 299V Pro-Viva
®
Improved global symptoms <0.05
Niedzielin
64
40 1 L. plantarum 299v Pro-Viva
®
Improved global symptoms <0.01
Kim
5
25 2 D-IBS VSL#3
®
Reduced bloating <0.01 ITT
O’Mahony
6
77 2 B. infantis versus L. salivarius B. infantis: improved global symptoms and <0.05
anti-inflammatory cytokine profile
L. salivarius: no benefit NS
Kajander
65
103 6 Mixture (2 strains of L. rhamnosus, B. breve, Improved global symptoms 0.015
P. freudenreichii)
Bittner
66
25 0.5 29 bacteria + prebiotic Prescript-Assist
®
Improved wellbeing <0.05
O’Sullivan
67
25 1 Lactobacillus GG No benefit NS
Sen
68
12 1 L. plantarum 299V Pro-Viva
®
No benefit **Study design flawed NS
Bausserman
69
50 1.5 Lactobacillus GG No benefit NS
Niv
70
39 6 Lactobacillus GG No benefit **Francis Severity IBS Score NS
Kim
71
48 1 or 2 VSL#3
®
Reduced flatulence, retarded colonic transit <0.05
Whorwell
12
362 1 B. infantis 35624 Improved global symptoms <0.02
Gawronska
9
104 1 Lactobacillus GG Reduced frequency of pain 0.02
Moon
11
34 1 B. subtilis, S. faecium Reduced frequency of pain <0.05
Marteau
10
116 1 Lactibiane
®
(4 strains of B. longum, Reduced pain 0.023
L. acidophilus, L. lactis, Increased colonic transit in those with constipation 0.043
S. thermophilus)
Simren
8
76 1.5 L. plantarum 299V No benefit NS
Simren
7
118 2 L. paracasei ssp paracasei No benefit NS
is completed, there appears to be no hard evidence to recommend the use diarrhea.
31
Although the studies reviewed were of good quality, with a trend
of probiotics for the treatment of infectious diarrhea. favoring the therapeutic use of probiotics, the intention-to-treat analysis
indicated that there was no significant difference between the treatment
Radiation-induced Diarrhea and placebo study arms. Although the review was limited to pediatric
A randomized controlled trial has been conducted examining the efficacy of studies, it is logical to extrapolate this finding to an adult population.
VSL#3 in the prevention of radiation-induced diarrhea among patients
receiving adjuvant radiation therapy for the management of colorectal or Inflammatory Bowel Disease
cervical cancers.
24
In this study of 482 patients, those who received three A disturbance in the gastrointestinal microflora, or the host response to this
sachets per day of the probiotic mixture experienced radiation-induced flora, has been demonstrated to play a critical role in the pathogenesis of
diarrhea significantly less often than those receiving an identical-appearing inflammatory bowel disease (IBD). This has led to attempts to modify the
placebo (31.6 versus 51.8%). Most impressive was the much lower bacterial flora with probiotics, as reviewed in detail elsewhere.
32,33
While
frequency at which VSL#3-treated patients experienced diarrhea rated as differences in intestinal flora between healthy individuals and those with IBD
severe (1.4%) compared with placebo-treated patients (55.4%). Because have been well documented, it remains unclear whether regional patterns of
these results are both clinically and statistically significant, this suggests a colonization in the bowels of IBD patients might contribute to disease
preventive role for probiotics for radiation-induced colitis, but does not phenotype. Two recent studies comparing bacterial populations using 16S
provide information on whether probiotics could be used in the treatment ribosomal RNA (rRNA) analysis from specific biopsy samples have advanced
of such patients already experiencing diarrhea. our understanding in this area.
34,35
In the first study, by Bibiloni et al.,
34
biopsy
samples were taken from the intestines of healthy controls and from both
Antibiotic-associated and Clostridium difficile Diarrhea healthy and inflamed intestinal regions of patients with ulcerative colitis (UC)
The efficacy of probiotics in both Clostridium difficile diarrhea and antibiotic- and Crohn’s disease (CD). They found similar bacterial compositions in
associated diarrhea has been reviewed, confirming an odds ratio of 0.37 in healthy and diseased regions within patients, a greater overall bacterial
favor of probiotic treatment over placebo in preventing diarrhea associated population in UC than CD patients, and a different variety of bacterial species
with antibiotics.
25–27
The largest randomized, controlled trial to date in between the IBD subgroups, with CD patients having a greater number of
C. difficile-associated colitis
28
demonstrated that Saccharomyces boulardii Bacteroidetes. The second study, by Zhang et al., looked solely at differences
was able to prevent disease recurrence, but only in those individuals who had between bacterial populations in healthy and diseased regions of the colons
had more than one sequential C. difficile infection. Similar results were found of UC patients.
35
While the dominant bacterial strain between regions within
in two later trials by Wullt et al.
29
and Rafiq et al.
30
an individual was highly similar, compositions of Lactobacilli and Clostridium
species varied considerably between diseased and healthy regions of an
In 2007, the Cochrane collaboration presented its findings regarding the individual’s colon. Taken together, the results of these trials do not point to a
use of probiotics for the prevention of pediatric antibiotic-associated single abnormality that can be targeted in IBD therapy, but do suggest that
44 US GASTROENTEROLOGY
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