NCT03377933

The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection

The Effects of Compound Lactobacillus Acidophilus Has on Gastromicroecology and Combined With Tetracycline- and Furazolidone- Containing Quadruple Regimen as Rescue Treatment for Helicobacter Pylori Infection

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yiqi Du · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for H. pylori infection. Eradication was evaluated using the 13C-urea breath test at 4 weeks after the end of therapy, and side effects were recorded. Besides study gene-level changes in the gastric microbiota following use of probiotics.

Detailed description

Currently the infection rate of H. pylori is high. H. pylori infection has a close relationship with human diseases , Among the patients with H. pylori infection, 100% have active gastritis, \<10% show H. pylori related dyspepsia, 15%\~20% develop into peptic ulcer, \<1% ultimately evolve into gastric malignant tumor. H. pylori gastritis has been defined as an infective disease. Eradication of H. pylori plays an important role in the cure, reversal and delay of these diseases. With the widespread eradication of H. pylori, antibiotics resistance rates are increasing seriously. The resistance of antibiotics results in the increase of H. pylori eradication failure rate. Choosing a safe and effective scheme for patients who have failed multiple times is a challenge for the clinicians. Besides, both domestic and international consensuses point that the application of some probiotics can reduce adverse effects through regulating gastric microenvironment, and it is still controversial about whether probiotics can inhibit H. pylori to increase the eradication rate. Investigators previously retrospectively analyzed 30 patients with H. pylori eradication failures at least two times given two-week compound Lactobacillus acidophilus followed with 10-day tetracycline- and furazolone- containing quadruple regimen, the ITT eradication rate was 92.1%, and 94.6% PP analysis. Side effects were mild mainly including dizziness, dry mouth and skin rash occurred in eight patients.

Conditions

• Efficacy
• Gastric Microbiota
• Safety

Interventions

Type	Name	Description
OTHER	Compound Lactobacillus acidophilus	Compound Lactobacillus acidophilus Tablet

Timeline

• Start date: 2019-03-15
• Primary completion: 2020-03-01
• Completion: 2020-03-15
• First posted: 2017-12-19
• Last updated: 2019-06-24

Locations

1 site across 1 country: China