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

NCT03377933 | Unknown DMC

• 1 other identifier: chbs230023-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy; Gastric Microbiota; Safety

Keywords

Helicobacter pylori; Probiotics; Efficacy; Safety; gastromicroecology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• eradication rate of the therapy

  4 weeks

• the incidence of the adverse effects

  2 weeks, 4 weeks

Study Arms (1)

probiotics and quadruple therapy

EXPERIMENTAL

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

Interventions

Compound Lactobacillus acidophilus OTHER

Compound Lactobacillus acidophilus Tablet

Also known as: Yi Jun Kang

probiotics and quadruple therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Yiqi Du: lead

Study Sites (1)

Changhai hospital

Shanghai, China

RECRUITING

Study Officials

• Yi Qi Du, professor

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Qi Du, professor

CONTACT

+8613801993592; duyiqi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director of Department of Gastroenterology

Model Details: Single-center exploratory study

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 19, 2017
• Study Start: March 15, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 15, 2020
• Last Updated: June 24, 2019

Record last verified: 2019-06

Locations

CN (1)