BACKGROUND: This study was performed to evaluate whether the addition of probiotics to proton pump inhibitor (PPI)-based triple therapy increases the likelihood of successful Helicobacter pylori eradication. MATERIALS AND METHODS: Three hundred and forty-sevenH. pylori-infected patients were randomized into a triple-plus-yogurt group (yogurt group, n = 168) or a triple-only group (control group, n = 179). Triple therapy consisted of PPI b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for 7 days. Yogurt group received triple therapy for 1 week and one bottle of Will yogurt per day for at 3 weeks, starting on the first day of triple therapy. Will yogurt (a Korean brand) contains Lactobacillus acidophilus HY2177, Lactobacillus casei HY2743, Bifidobacterium longum HY8001, and Streptococcus thermophilus B-1. (13)C-urea breath test was performed at least 4 weeks after completion of triple therapy. Eradication rates, compliances, and adverse events were compared. RESULTS: By intention-to treat analysis the H. pylori eradication rates in the yogurt group 79.2% (133 of 168) was similar to that in the control group 72.1% (129 of 179) (p = .124). However, by per-protocol (PP) analysis, the eradication rate in the yogurt group, 87.5% (133 of 152) was higher than that in the control group, 78.7% (129 of 164) (p = .037). Common adverse events were metallic taste (11.8%) and diarrhea (8.6%). The frequency of adverse effects in the yogurt group 41.1% (69/168) were higher than in the control group, 26.3% (47 of 179) (p = .003). However, most adverse events were mild to moderate in intensity, and the severities of adverse effects were similar in both groups (p = .401). CONCLUSIONS: The addition of Will yogurt to triple therapy did not reduce the side-effects of triple therapy. But it increased the H. pylori eradication rate by PP analysis, encouraging more research in this field.
RCT Entities:
BACKGROUND: This study was performed to evaluate whether the addition of probiotics to proton pump inhibitor (PPI)-based triple therapy increases the likelihood of successful Helicobacter pylori eradication. MATERIALS AND METHODS: Three hundred and forty-seven H. pylori-infectedpatients were randomized into a triple-plus-yogurt group (yogurt group, n = 168) or a triple-only group (control group, n = 179). Triple therapy consisted of PPI b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for 7 days. Yogurt group received triple therapy for 1 week and one bottle of Will yogurt per day for at 3 weeks, starting on the first day of triple therapy. Will yogurt (a Korean brand) contains Lactobacillus acidophilus HY2177, Lactobacillus casei HY2743, Bifidobacterium longum HY8001, and Streptococcus thermophilus B-1. (13)C-urea breath test was performed at least 4 weeks after completion of triple therapy. Eradication rates, compliances, and adverse events were compared. RESULTS: By intention-to treat analysis the H. pylori eradication rates in the yogurt group 79.2% (133 of 168) was similar to that in the control group 72.1% (129 of 179) (p = .124). However, by per-protocol (PP) analysis, the eradication rate in the yogurt group, 87.5% (133 of 152) was higher than that in the control group, 78.7% (129 of 164) (p = .037). Common adverse events were metallic taste (11.8%) and diarrhea (8.6%). The frequency of adverse effects in the yogurt group 41.1% (69/168) were higher than in the control group, 26.3% (47 of 179) (p = .003). However, most adverse events were mild to moderate in intensity, and the severities of adverse effects were similar in both groups (p = .401). CONCLUSIONS: The addition of Will yogurt to triple therapy did not reduce the side-effects of triple therapy. But it increased the H. pylori eradication rate by PP analysis, encouraging more research in this field.