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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03297242
• Other study ID #: chbs230023
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2017
• Last updated: December 6, 2017
• Start date: December 2017
• Est. completion date: September 2018

Study information

• Verified date: December 2017
• Source: Changhai Hospital
• Contact: Yi Q Du, MD
• Phone: +86-13801993592
• Email: duyiqi[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urea breath test	if urea breath test is negative,it means H pylori eradicated successfully	4-6 weeks after the quadruple therapy
Secondary	adverse effects	adverse effects mean the new symptoms during the treatment process,such as nausea,vomiting.	1month