Table 2.
Studies comparing capsule based probiotic (bacteria only) with placebo or standard therapy plus capsule based probiotic vs standard therapy
| Ref. | Type of trial | Evidence grade1 | Quality rating2 | Subjects | Study design | Study groups/ methods | Outcome variable/s | Results and conclusions |
| Positive | ||||||||
| Canducci et al[27], Italy, 2000 | Human | 1+ | + | 120 H. pylori positive patients | RCT | Two groups: RCA (Rabeprazole, Clarithromycin, Amoxycillin) group- triple therapy (n = 60), RCAL group- triple therapy with Lactéol Fort for 7 d | Effect of L. acidophilus could improve the efficacy of a standard anti-H. pylori therapy | In RCA group eradication was successful in 72% at PP analysis or 70% at ITT analysis and in RCAL group eradication was achieved with 88% with PP analysis, 87% with ITT analysis |
| Negative | ||||||||
| Gotteland et al[28], 2005 | Human | 1+ | + | 254 children positive for H. pylori | RCT | Three groups: Antibiotics (group Ab)- (n = 57) for 8 d, Lactobacillus acidophilus LB (group Ab)- (n = 63) for 8 wk, Saccharomyces boulardii plus inulin (group Sb1)- (n = 62) 8 wk | To evaluate the capacity of Lactobacillus acidophilus LB and of symbiotic combination of Sb plus inulin to interfere with H. pylori colonization in children | H. pylori was eradicated in 66%, 12% and 6.5% of the children from the Ab, Sb1 and LB groups, respectively. A moderate but significant difference in ∆ DOB was detected in children receiving living Sb1, but not in those receiving LB |
| Lionetti et al[29], 2006, Italy | Human | 1+ | ++ | 40 H. pylori positive children | RCT | Two groups: Group A- 10 d sequential therapy plus L. reuteri ATCC 55730, Group B-Placebo with the same therapy | Effect of Lactobacillus reuteri to prevent or minimize the gastrointestinal side-effects | No significant differences were observed between the groups in the success of H. pylori eradication. Treatment was successful in 17 of 20 [85% (95%CI: 68-100)] patients in probiotic supplemented when compared with 16 of 20 patients in placebo group [80% (95%CI: 61–99)] (P = NS) |
| Nista et al[30], 2004, Italy | Human | 1+ | ++ | 106 H. pylori positive patients | RCT | Two groups: Group A- triple therapy for 7 d plus Bacillus clausii (probiotic) for 14 d starting from the first day of the treatment (n = 54) Group B- triple therapy plus placebo (n = 52) | Effect of probiotic on incidence and severity of antibiotic-associated side-effects during anti- H. pylori therapy and eradication was evaluated with means of 13C-urea breath test | The H. pylori eradication rate was similar between B. B. clausii and placebo groups. In particular, ITT analysis has shown H. pylori was eradicated in 39 of 54 patients (72.2%) in the B. clausii group and in 37 of 52 patients (71.15%) in the placebo group. In PP population, H. pylori was eradicated in 39 of 50 patients (78%) in the B. clausii group and in 37 of 50 patients (74%) in the placebo group |
| Myllyluoma et al[31], 2005, Finland | Human | 1+ | + | 47 subjects with H. pylori infection | CCT | Two groups: Group A –probiotic drink (n = 23), group B- Placebo (n = 24) during H. pylori eradication and for 3 wk following the treatment | Effect of probiotic therapy on symptoms associated with the recommended H. pylori eradication treatment. As a secondary end-point to find out whether this therapy could improve the eradication rate | The H. pylori eradication rate was non-significantly higher in the group receiving probiotic therapy (91% vs 79%, P = 0.42) |
| Cindoruk et al[32], 2007, Turkey | Human | 1+ | + | 124 patients with H. pylori infection | RCT | Two groups: Group A- triple therapy plus S. boulardii, Group B- triple therapy plus placebo for 14 d | Efficacy and safety of S. boulardii in the prevention of side effects and the eradication success of anti-H. pylori therapy | H. pylori eradication rate, although higher in the treatment group, was statistically similar in treatment and control groups: 71% (44/62) vs 59.7% (37/62), respectively (P > 0.05) |
| Armuzzi et al[33], 2001, Italy | Human | 1+ | + | 60 healthy asymptomatic subjects screened positive for H. pylori infection | CCT | Two groups: Group A- triple therapy for 7 d plus Lactobacillus GG for 14 d during and the week after eradication therapy, Group B- triple therapy plus placebo | Effect of probiotic Lactobacillus GG to minimize or to prevent the occurrence of gastrointestinal side effects | H. pylori eradication rates in group A was 83.33% (25/30) and in group B was 80% (24/30). H. pylori eradication rate had no significant difference |
| Guo et al[34], China, 2004 | Human | FT NA | FT NA | 97 H. pylori positive symptomatic patients | CCT | Two groups: treatment group (triple therapy plus Bifid triple viable capsule containing Bifidobacteria longum, faecal streptococci, Lactobacillus acidophilus) (n = 47) control group: triple therapy (n = 50) | Efficacy of probiotic in the treatment of H. pylori | Eradication rate was 93.6% (44/47) in treatment group and 88% in control group (44/50). H. pylori eradication rate had no significant difference |
| Armuzzi et al[35], 2001, Italy | Human | FT NA | FT NA | 120 healthy asymptomatic subjects screened positive for H. pylori infection | CCT | Two groups: Group A- triple therapy for 7 d plus Lactobacillus GG for 14 d during and the week after eradication therapy, Group B- triple therapy plus placebo | Effect of probiotic Lactobacillus GG to minimize or to prevent the occurrence of gastrointestinal side effects. | H. pylori eradication rates in group A was 80% (48/60) and in group B was 76.67% (46/60). H. pylori eradication rate had no significant difference |
| Cremonini et al[36], Italy, 2002 | Human | FT NA | FT NA | 85 H. pylori positive, asymptomatic patients | CCT | Four groups- received both during and for 7 d after a 1 wk-triple therapy Group I- Lactobacillus GG (n = 21), group II-Saccharomyces boulardii (n = 22), group III-lactobacillus spp. And bifidobacteria (n = 21), group IV-placebo (n = 21) | Efficacy of probiotic in the eradication of H. pylori infection | The H. pylori eradication rate was almost identical between the probiotic and placebo groups |
| Tursi et al[37], 2004, Italy | Human | FT NA | FT NA | 70 patients with persistent H. pylori infection | CCT | Two groups- group A- quadruple therapy plus bacteria lactobacillus casei subsp. casei DG or group B- quadruple therapy only | Effect of probiotic supplementation on the effectiveness and tolerability of a new second-line 10 d quadruple therapy | H. pylori was negative in 33/34 group A patients (PP: 97.05% ITT: 94.28%) and 30/32 Group B patients |
| Cao et al[38], China, 2005 | Human | FT NA | FT NA | 128 H. pylori positive symptomatic patients | CCT | Two groups: Group A -quadruple therapy plus Clostridium butyricum group B- quadruple therapy | Effect of treatment given in eradication of H. pylori | Eradication rates in group A 96.88% (62/64) and group B 92.19% (59/64) was not significantly different |
Levels of evidence: 1++ High quality meta-analysis, systematic reviews of RCTs, or RCTs with a very low risk of bias; 1+ Well conducted meta-analysis, systematic reviews of RCTs or RCTs with a low risk of bias; 1- Meta-analysis, systematic reviews or RCTs or RCTs with a high risk of bias; 2++ High quality systematic reviews of case-control or cohort studies or high quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal; 2+ Well conducted case control or cohort studoes with a low risk of confounding, bias, or chance and a significant risk that the relationship is not causal; 3 Non-analytic studies, e.g., case reports, case series; 4 Expert opinion.
Quality rating for individual studies: ++ Applies if all or most criteria from the checklist are fulfilled; where criteria are not fulfilled the conclusions of the study or review are thought very unlikely to alter; + Applies if some of the criteria from the checklist are fulfilled; where criteria are not fulfilled or are not adequately described, the conclusions of the study or review are thought unlikely to alter; - Applies if few or no criteria from the checklist are fulfilled; where criteria are not fulfilled or are not adequately described, the conclusions of the study or review are thought likely or very likely to alter. H. pylori: Helicobacter pylori; RCT: Randomised controlled trial; CCT: Controlled clinical trial; CT: Clinical trial; NR: Not reported; NS: Not significant.