Safety Clinical Trial
Official title:
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
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.
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.
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