Table 3.
Publication (year, country) | First author | Type of intervention | Agent used | N | Control group | Intervention group | Primary end point | Statistical benefit (P-value) | Trend toward clinical benefit or harm |
---|---|---|---|---|---|---|---|---|---|
1997, Germany | Kruis49 | Probiotic | Escherichia coli Nissle 1917 | 103 | 53 | 50 | Remission and relapse rate | No (>0.05) | None |
1999, UK | Rembacken50 | Probiotic | Nonpathogenic strain of Escherichia coli (serotype O6:K5:H1) Nissle 1917 | 116 | 59 | 57 | Remission and relapse rate | No (>0.05) and yes (0.0059) | Benefit |
2003, Japan | Ishikawa51 | Probiotic | Bifidobacteria-fermented milk | 21 | 10 | 11 | Clinical relapse and duration of remission | Yes (0.0059 and 0.0174) | Benefit |
2004, Germany | Kruis52 | Probiotic | Escherichia coli Nissle 1917 | 327 | 165 | 162 | Rate of relapse | Yes (0.003) | Benefit |
2004, People’s Republic of China | Cui53 | Probiotic | Bifid Triple Viable capsule | 30 | 15 | 15 | Rate of relapse and fecal/mucosal response | Yes (<0.01 and <0.05) | Benefit |
2006, Italy | Zocco54 | Probiotic | LGG LGG + mesalazine |
187 | 62 | 65,* 60** | Maintenance of clinical remission | No (>0.05) | Benefit |
2009, Japan | Fujimori55 | Probiotic, prebiotic, synbiotic | Bifidobacterium longum, psyllium, combined | 120 | 0 | 40,a 40,b 40c | Improvement in quality of life: IBDQ score | Yes (0.03) | Benefit |
2009, Italy | Miele56 | Probiotic | VSL#3 | 29 | 15 | 14 | Maintenance of remission and relapse rate | Yes (<0.01 and 0.014) | Benefit |
2009, Denmark | Wildt57 | Probiotic |
Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. Lactis BB-12 |
32 | 12 | 20 | Maintenance of clinical remission | No (0.37) | Benefit |
2010, Egypt | Hegazy58 | Probiotic | Lactobacillus delbruekii and Lactobacillus fermentum | 30 | 15 | 15 | Decrease in colonic inflammation | Yes (<0.05) | Not applicable |
2011, Japan | Ishikawa59 | Synbiotic | Bifidobacterium breve Yakult and galacto-oligosaccharide | 41 | 20 | 21 | Endoscopic score: Matt’s Classification | Yes (<0.05) | Benefit |
2012, Italy | Oliva60 | Probiotic | Lactobacillus reuteri ATCC 55730 | 31 | 15 | 16 | Clinical and endoscopic remission: Mayo Score and inflammatory markers | Yes (<0.01) | Benefit |
Notes: Randomized controlled trials that have studied the use of various probiotic/prebiotic/synbiotic agents in the treatment of either induction, maintenance, or induction + maintenance of ulcerative colitis with primary end points, number of patients involved in the study, and outcomes as shown.
LGG agent used.
LGG + mesalazine agent used.
Probiotic type of intervention.
Prebiotic type of intervention.
Synbiotic type of intervention.
Abbreviations: ATCC, American Type Culture Collection; IBDQ, Inflammatory Bowel Disease Questionnaire; LGG, Lactobacillus GG; N, total number of patients enrolled in the study at the beginning of the study.