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The Associations Between the Gastric Mucosal Pathology and the Eradication Rate of H.Pylori :A Multicenter Study

S

Shandong University

Status

Unknown

Conditions

Helicobacter Pylori

Treatments

Drug: bismuth-containing quadral therapy based on antibiotic susceptibility

Study type

Interventional

Funder types

Other

Identifiers

NCT04030715
2018SDU-QILU-G113

Details and patient eligibility

About

Use the two-categorical variable , eradicate success or failure ,as a dependent variable, and analyze the influential factors by logistic regression.And then the statistically significant influencing factors like gastric mucosal pathology are obtained.We build a predictive model of the outcome of Hp eradication therapy based on significant influencing factors. The difference with p 0.05 is statistically significant.

Full description

The subjects who are naiive Hp infection patients recieved the Hp eradication therapy based on antimicrobial susceptibility test.Using success or failure of eradication as a dependent variable, analyze the influential factors by logistic regression.And then the statistically significant influencing factors like gastric mucosal pathology are obtained.We build a predictive model of the outcome of Hp eradication therapy based on significant influencing factors. The difference with p<0.05 is statistically significant.

Enrollment

1,200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion criteria

  • Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, patient with peptic ulcer, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

1,200 participants in 2 patient groups

the successful group
Other group
Description:
divide the subject to two groups based on the success or failure of eradication, and analyze the influential factors of eradication. Build a predictive model for the success of eradication.
Treatment:
Drug: bismuth-containing quadral therapy based on antibiotic susceptibility
the failure group
Other group
Description:
divide the subject to two groups based on the success or failure of eradication, and analyze the influential factors of eradication. Build a predictive model for the success of eradication.
Treatment:
Drug: bismuth-containing quadral therapy based on antibiotic susceptibility

Trial contacts and locations

1

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Central trial contact

Xiuli H Zuo, MD,PhD; Tian Ma, MD

Data sourced from clinicaltrials.gov

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