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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03297242
Other study ID # chbs230023
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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