COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03377933
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : June 24, 2019
Information provided by (Responsible Party):
Yiqi Du, Changhai Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Efficacy Gastric Microbiota Safety Other: Compound Lactobacillus acidophilus Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-center exploratory study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

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 Name: Yi Jun Kang

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. eradication rate of the therapy [ Time Frame: 4 weeks ]
    using the 13C-urea breath test at 4 weeks after the end of therapy

  2. the incidence of the adverse effects [ Time Frame: 2 weeks, 4 weeks ]
    record the side effects on the 2 week, 4 week.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03377933

Layout table for location contacts
Contact: Yi Qi Du, professor +8613801993592

Layout table for location information
Changhai hospital Recruiting
Shanghai, China
Contact: Yiqi Du         
Sponsors and Collaborators
Yiqi Du
Layout table for investigator information
Principal Investigator: Yi Qi Du, professor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Layout table for additonal information
Responsible Party: Yiqi Du, Vice Director of Department of Gastroenterology, Changhai Hospital Identifier: NCT03377933    
Other Study ID Numbers: chbs230023-1
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: study protocal

Layout table for additional information
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
Keywords provided by Yiqi Du, Changhai Hospital:
Helicobacter pylori
Additional relevant MeSH terms:
Layout table for MeSH terms