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

Primary Purpose

Efficacy, Gastric Microbiota, Safety

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Compound Lactobacillus acidophilus
Sponsored by
Yiqi Du
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy focused on measuring Helicobacter pylori, Probiotics, Efficacy, Safety, gastromicroecology

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Changhai hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

probiotics and quadruple therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

gene-level changes in the gastric microbiota
study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2017
Last Updated
June 20, 2019
Sponsor
Yiqi Du
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1. Study Identification

Unique Protocol Identification Number
NCT03377933
Brief Title
The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yiqi Du

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Gastric Microbiota, Safety
Keywords
Helicobacter pylori, Probiotics, Efficacy, Safety, gastromicroecology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center exploratory study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
probiotics and quadruple therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Compound Lactobacillus acidophilus
Other Intervention Name(s)
Yi Jun Kang
Intervention Description
Compound Lactobacillus acidophilus Tablet
Primary Outcome Measure Information:
Title
gene-level changes in the gastric microbiota
Description
study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
eradication rate of the therapy
Description
using the 13C-urea breath test at 4 weeks after the end of therapy
Time Frame
4 weeks
Title
the incidence of the adverse effects
Description
record the side effects on the 2 week, 4 week.
Time Frame
2 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Qi Du, professor
Phone
+8613801993592
Email
duyiqi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Qi Du, professor
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiqi Du

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
study protocal

Learn more about this trial

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

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