Abstract
BACKGROUND: Lactobacillus paracasei and Glycyrrhiza glabra have been reported as having beneficial effects on Helicobacter pylori infection. We aimed to assess the efficacy and safety of fermented milk containing L paracasei HP7 and G glabra in patients with H pylori infection. METHODS: This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted in 2 hospitals from April to December 2017. Patients with H pylori infection were randomized into either the treatment group (fermented milk with L paracasei HP7 and G glabra) or placebo group (fermented milk only) once daily for 8 weeks. The primary endpoint was the gastric load of H pylori measured by C-urea breath test (UBT). Secondary endpoints were histologic and clinical improvement. RESULTS: A total of 142 patients were randomly allocated to the treatment (n = 71) or placebo groups (n = 71). Compared to baseline data, the quantitative value of C-UBT at 8 weeks was significantly reduced in the treatment group (from 20.8 ± 13.2% to 16.9 ± 10.8%, P = .035), but not in the placebo group (P = .130). Chronic inflammation improved significantly only in the treatment group (P = .013), whereas the neutrophil activity deteriorated significantly only in the placebo group (P = .003). Moreover, the treatment group had significant improvement in gastrointestinal symptoms (P = .049) and quality of life (P = .029). No serious adverse events were observed. CONCLUSION: The combination of fermented milk containing L paracasei and G glabra reduced H pylori density and improved histologic inflammation. However, their mechanisms of action should be elucidated in further studies.