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

• Conditions: Helicobacter Pylori Infection

• Registration Number: NCT03297242
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-09-23
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-09-29
• Status Verified: 2017-12
• Study Start: 2017-12
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-07
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urea breath test	4-6 weeks after the quadruple therapy	if urea breath test is negative,it means H pylori eradicated successfully

Secondary Outcome Measures

Name	Time	Method
adverse effects	1month	adverse effects mean the new symptoms during the treatment process,such as nausea,vomiting.