Fermented milk containing Lactobacillus paracasei and Glycyrrhiza glabra has a beneficial effect in patients with Helicobacter pylori infection: A randomized, double-blind, placebo-controlled study.
- 2019-08
- Medicine 98(35)
- Jin Young Yoon
- Jae Myung Cha
- Seong Soo Hong
- Hyung Kyung Kim
- Min Seob Kwak
- Jung Won Jeon
- Hyun Phil Shin
- PubMed: 31464895
- DOI: 10.1097/md.0000000000016601
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 142
- Population
- 142 patients with H pylori infection
- Methods
- multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial; treatment group received fermented milk with L paracasei HP7 and G glabra, placebo group received fermented milk only, once daily for 8 weeks
- Blinding
- Double-blind
- Duration
- 8 weeks
- Funding
- Unclear
- Large Human Trial
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.Research Insights
Chronic inflammation improved significantly only in the treatment group (P = .013)
- Effect
- Beneficial
- Effect size
- Small
the treatment group had significant improvement in gastrointestinal symptoms (P = .049)
- Effect
- Beneficial
- Effect size
- Small
the treatment group had significant improvement in ... quality of life (P = .029)
- Effect
- Beneficial
- Effect size
- Small
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)
- Effect
- Beneficial
- Effect size
- Small
the neutrophil activity deteriorated significantly only in the placebo group (P = .003)
- Effect
- Neutral
- Effect size
- Small