Study the Effect of Probiotics Combined With Bismuth Quadruple Rescue Therapy on H Pylori Infective Patients

A Retrospective Study of the Efficacy of Compound Lactobacillus Acidophilus Combined With Bismuth Quadruple Rescue Therapy on Patients With H Pylori Eradication Failures

Retrospectivly follow-up the outpatients for H pylori eradication failures more than 2 times in the digestive department of Changhai hospital from 2015-2017,analyse the eradication rates and adverse effects of the therapy with 2w's compound lactobacillus acidophilus followed by 10d's bismuth, furazolidone, tetracycline contained quadruple scheme.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection

Detailed Description

H pylori infection rate has been up to half of the world population. H pylori infection is associated with various diseases, especially gastric cancer.

With the increasingly resistant to antibiotics,the eradication rate has decreased a lot with traditional triple therapy. Exploring a valid scheem for patients who have failed multiple times is important.

Probiotics can improve gastrointestinal microenvironment, then release the adverse effects during the eradication process.Additionally,there is also a lot evidence that probiotics can inhibit H plori，but still controversially.

There is a low resistant rate about furazolidone and tetracycline. In this study investigators observe the efficacy of the therapy 2w's compound lactobacillus acidophilus followed by 10d's bismuth, furazolidone, tetracycline contained quadruple scheme on patients who have failed more than 2 times. 4 to 6 weeks after the therapy, if Urea Breath Test (UBT) is nedative which means eradicating H plori successfully.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Yi Q Du, MD; Phone Number: +86-13801993592; Email: duyiqi@hotmail.com
• Study Contact Backup: Name: Ai R Liu, MM; Phone Number: +86-13701798230; Email: 13701798230@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

mainland in China

Description

Inclusion Criteria:

• H pylori eradication had failed more than 2 times
• Patients had never used furazolone and tetracycline
• The age varied from 18 to 80 years old

Exclusion Criteria:

• H pylori initial eradication or had failed only 1 time
• The age was lower than 18,or higher than 80 years old
• Patients who had serious heart pulmonary disease ,live renal disease, or any cancers
• Pregnant women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urea breath test	if urea breath test is negative,it means H pylori eradicated successfully	4-6 weeks after the quadruple therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effects	adverse effects mean the new symptoms during the treatment process,such as nausea,vomiting.	1month

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Zhao S Li, MD

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: September 23, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Helicobacter Pylori eradication
• Other Study ID Numbers: chbs230023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No