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

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.

Study Overview

• Status: Unknown
• Conditions: Efficacy; Safety; Gastric Microbiota
• Intervention / Treatment: Other: Compound Lactobacillus acidophilus

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Changhai Hospital
    • Contact: Yiqi Du

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: Yi Jun Kang

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gene-level changes in the gastric microbiota	study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eradication rate of the therapy	using the 13C-urea breath test at 4 weeks after the end of therapy	4 weeks
the incidence of the adverse effects	record the side effects on the 2 week, 4 week.	2 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: Yiqi Du
• Investigators: Principal Investigator: Yi Qi Du, professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 15, 2020

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 16, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Probiotics; Helicobacter pylori; gastromicroecology
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: chbs230023-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: study protocal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No