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Probiotics in the Treatment of Gastrointestinal Diseases
Table 2: Clinical Trials of Probiotics in Ulcerative Colitis
Reference Methodology n Treatments Results
Treatment of acute ulcerative colitis
Kato
72
RCT 20 Bifidobacterium-fermented milk versus placebo (both groups on aminosalicylates) p<0.01
Rembacken
36
RCT 116 E. coli Nissle 1917 versus mesalamine (both had prednisolone induction) p=NS
Bibiloni
42
Open-label 30 VSL#3 63% remission
Guslandi
44
Open-label 25 S. boulardi 68% remission
Borody
46
Open-label 6 Fecal enemas 100% remission
Maintenance of medically induced remission
Rembacken
36
RCT 116 E. coli Nissle 1917 versus mesalamine p=NS*
Kruis
37
RCT 327 E. coli Nissle 1917 versus mesalamine Equivalency
demonstrated
Ishikawa
43
RCT 21 Yakult versus placebo p<0.02
Venturi
73
Open-label 20 VSL#3 75% still in remission
at 1 year
* Study not designed to test equivalency. RCT = randomized controlled trial.
Table 3: Clinical Trials of Probiotics in Pouchitis
Reference Methology n Treatments Results
Maintenance of antibiotic-induced remission
Gionchetti
74
RCT 40 VSL#3 versus placebo p<0.001
Mimura
50
RCT 36 VSL#3 versus placebo p<0.001
Shen
51
Open-label 31 VSL#3 versus placebo p=NS
Maintenance of surgically induced remission
Gionchetti
48
RCT 40 VSL#3 versus placebo p<0.05
Treatment of acute pouchitis
Kuisma
53
RCT 20 Lactobacillus GG versus placebo p=NS
Laake
52
Open-label 10 Cultura p=NS
RCT = randomized controlled trial.
Table 4: Clinical Trials of Probiotics in Crohn’s Disease
Reference Methology n Treatments Results
Treatment of active Crohn’s disease
Schultz
75
RCT 11 Lactobacillus GG versus placebo (plus initial antibiotics/steroids) p=NS
Gupta
76
Open-label 4 Lactobacillus GG ↓CDAI (p<0.02)
Maintenance of medically induced remission
Malchow
77
RCT 28 E. coli Nissle 1917 versus placebo p=NS
Guslandi
78
Open-label 32 S. boulardii versus mesalamine p<0.05
Maintenance of surgically induced remission
Prantera
79
RCT 45 Lactobacillus GG versus placebo p=NS
Chermesh
56
RCT 30 Synbiotic 2000 (P. pentoseceus, L. raffinolactis, L. paracasi susp p=NS
paracsei, L. plantarum 2362) and 4 fermentable fibers versus placebo
Van Gossum
55
RCT 70 L. johnsonii or placebo p=NS
CDAI = Crohn’s Disease Activity Index; RCT = randomized controlled trial.
regional differences in bacterial populations may play a role in IBD with inactive UC assessed E. coli Nissle 1917 against mesalamine and
pathogenesis, possibly providing clues to future therapeutic targets as the established statistical equivalence.
37
This was the best of all the evidence
volume of available data increases. supporting the use of probiotics for UC therapy, but unfortunately another
study assessing maintenance of remission in 120 patients using E. coli Nissle
Ulcerative Colitis 1917 failed to show any difference compared with placebo.
38
In 2006,
A summary of the clinical trials with probiotics in UC is shown in Table 2. The Matthes et al. reported a dose-dependent efficacy of the same probiotic,
largest study in the treatment of active colitis enrolled 116 patients who rectally administered, in the treatment of mild to moderate distal UC.
39
were randomized to Escherichia coli Nissle 1917 or standard-of-care
mesalamine therapy.
36
There was no difference in clinical outcomes between In a smaller study, patients with UC received BIFICO capsules (Enterococci,
groups, so the authors concluded equivalence between therapies. While this Bifidobacteria, Lactobacilli) to maintain remission induced by sulfasalazine.
40
trial was not powered to detect equivalence, a later study of 327 patients Patients receiving BIFICO demonstrated lower levels of pro-inflammatory
US GASTROENTEROLOGY 45
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