Table 3.
Some of the major human trials of probiotics for the treatment of gastrointestinal diseases.
| Probiotic strain | Disease | Number of participants | Reported outcome | Reference |
|---|---|---|---|---|
| Lactobacillus rhamnosus GG | H. pylori infection | 60 | Significant reduction (p = 0.04) of diarrhea, nausea and taste disturbances in the treatment group. | Armuzzi et al. (2001) |
| Antibiotic-associated diarrhea in children | 188 | Significant reduction of the incidence of antibiotic-associated diarrhea in children treated with oral antibiotics for common childhood infections. | Vanderhoof et al. (1999) | |
| 167 | The treatment effect on the incidence of diarrhea (95% confidence interval) was -11% (-21-0%). | Arvola et al. (1999) | ||
| B. bifidum | Irritable bowel syndrome | 122 | Overall responder rates (decrease in symptoms severity) were 57% in the treatment group, but only 21% in the placebo group (P = 0.0001). | Guglielmetti et al. (2011) |
| B. infantis | 362 | The improvement in overall symptom assessment exceeded the placebo by more than 20% (p < 0.02). | Whorwell et al. (2006) | |
| S. cerevisiae | 179 | The proportion of responders reporting improvement in abdominal pain/discomfort was significantly higher (p = 0.04) in the treated group than the placebo group (63% vs. 47%, OR = 1.88, 95%, CI: 0.99–3.57). | Pineton de Chamburn et al. (2015) | |
| VSL#3∗ | Pouchitis | 40 | Three patients (15%) in the treatment group had relapses of the disease within the 9-months follow-up period, compared with 20 (100%) in the placebo group (P < 0.001). | Gionchetti et al. (2000) |
| 40 | Two of the 20 patients (10%) in the treatment group had an episode of acute pouchitis compared with 8 of the 20 patients (40%) treated with placebo (log-rank test, z = 2.273; P < 0.05). | Gionchetti et al., 2003 | ||
| 34 | Treatment of patients with mild to moderate stages of disease, not responding to conventional therapy, with probiotic resulted in a combined induction of remission/response rate of 77% with no adverse events. | Bibiloni et al. (2005) | ||
| Ulcerative colitis | 124 | The efficacy of probiotic was significant (recurrence rate 34.6%, compared with 64.7% on placebo; p = 0.04) in patients with recurrent CDD, but not in patients with initial CDD (recurrence rate 19.3% compared with 24.2% on placebo; p = 0.86). | McFarland et al. (1994) | |
| Saccharomyces boulardii | Clostridium difficile-associated diarrhea (CDD) | 168 | A significant decrease in recurrence of CDD was observed only in patients treated with high-dose vancomycin (2 g/day) and probiotic (16.7%) compared with those who received high-dose vancomycin and placebo (50%; p = 0.05). | Surawicz et al. (2000) |
| 211 | The mean (+/-SD) duration of diarrhea was 1.69 days (0.6) in patients given probiotic, compared with 2.81 days (0.9) in those given placebo. | Buydens and Debeuckelaere (1996) | ||
| Enterococcus faecium SF68 | Antibiotic-associated diarrhea | 123 | The probiotic was shown to be effective in reducing the incidence of antibiotic-associated diarrhea (AAD) in comparison with placebo (8.7% compared with 27.2%, respectively). | Wunderlich et al. (1989) |
| Mixture of lactobacilli, bifidobacteria and streprococci | Travelers’ diarrhea | 94 | Prophylaxis with the probiotic significantly decreased the frequency of diarrhea from 71 to 43% (p = 0.019). | Black et al. (1989) |
| Mixture of B. infantis, B. bifidum, B. longum and L. acidophilus | Necrotizing enterocolitis in newborns | 186 | Enteral administration of the probiotic in neonatal intensive care setup significantly reduced morbidity due to necrotising enterocolitis in very low birth weight newborn. | Samanta et al. (2009) |
∗A mixture of Lactobacillus casei, L. plantarum, L. acidophilus, L. delbrueckii subsp. bulgaricus, B. longum, B. breve, B. infantis, and Streptococcus salivarius sp. Thermophiles.