The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection
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|ClinicalTrials.gov Identifier: NCT03377933|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : June 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Efficacy Gastric Microbiota Safety||Other: Compound Lactobacillus acidophilus||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-center exploratory study|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||March 15, 2020|
Experimental: probiotics and quadruple therapy
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
Other Name: Yi Jun Kang
- gene-level changes in the gastric microbiota [ Time Frame: 2 weeks ]study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics
- eradication rate of the therapy [ Time Frame: 4 weeks ]using the 13C-urea breath test at 4 weeks after the end of therapy
- the incidence of the adverse effects [ Time Frame: 2 weeks, 4 weeks ]record the side effects on the 2 week, 4 week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377933
|Contact: Yi Qi Du, firstname.lastname@example.org|
|Contact: Yiqi Du|
|Principal Investigator:||Yi Qi Du, professor||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|