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

Safety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03377933
• Other study ID #: chbs230023-1
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: June 2019
• Source: Changhai Hospital
• Contact: Yi Qi Du, professor
• Phone: +8613801993592
• Email: duyiqi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 15, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy
• Gastric Microbiota
• Safety

Intervention

Other:
• Compound Lactobacillus acidophilus
Compound Lactobacillus acidophilus Tablet

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Yiqi Du

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	eradication rate of the therapy	using the 13C-urea breath test at 4 weeks after the end of therapy	4 weeks
Secondary	the incidence of the adverse effects	record the side effects on the 2 week, 4 week.	2 weeks, 4 weeks