An interventional study of Compound Lactobacillus acidophilus in Efficacy, Gastric Microbiota and Safety, sponsored by Yiqi Du. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-24.
Sponsored by Yiqi Du · Not applicable, Interventional, and Treatment
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.
Yiqi Du is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Patients are given two-week compound Lactobacillus acidophilus probiotic (1 g t.i.d.), followed by a quadruple antibiotic regimen (esomeprazole \[20 mg b.i.d.\] + bismuth potassium citrate \[220 mg b.i.d.\] + tetracycline \[750 mg b.i.d.\] + furazolidone \[100 mg b.i.d.\]) for 10 days as rescue therapy.Meanwhile perform endoscopy and take gastric mucosa specimens for gene sequencing before and after the application of probiotic.
Other: Compound Lactobacillus acidophilus
Compound Lactobacillus acidophilus Tablet
Also known as: Yi Jun Kang
gene-level changes in the gastric microbiota
study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics
Time frame: 2 weeks
eradication rate of the therapy
using the 13C-urea breath test at 4 weeks after the end of therapy
Time frame: 4 weeks
the incidence of the adverse effects
record the side effects on the 2 week, 4 week.
Time frame: 2 weeks, 4 weeks
Plan to share: Undecided — study protocal
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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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