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

Yiqi Du40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Efficacy Gastric Microbiota Safety

Interventions

Compound Lactobacillus acidophilusOTHER

Compound Lactobacillus acidophilus Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All included patients were 18 to 70 years-old; negative for the urea breath test at least 4 weeks after last eradication treatment; and experienced at least 2 H. pylori eradication failures. Exclusion Criteria: * Patients were excluded if they presented with a severe comorbidity or a malignant tumor; had a known history of allergy to the drugs in the therapeutic regimen; used nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotic therapy, or bismuth salts up to 4 weeks before study inclusion; or were pregnant or breast-feeding.

Locations (1)

Changhai hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Yi Qi Du, professor

CONTACT

+8613801993592 duyiqi@hotmail.com

Data from ClinicalTrials.gov

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