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

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ClinicalTrials.gov Identifier: NCT03297242
Recruitment Status : Not yet recruiting
First Posted : September 29, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, 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.

Condition or disease
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
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018



Primary Outcome Measures :
  1. urea breath test [ Time Frame: 4-6 weeks after the quadruple therapy ]
    if urea breath test is negative,it means H pylori eradicated successfully


Secondary Outcome Measures :
  1. adverse effects [ Time Frame: 1month ]
    adverse effects mean the new symptoms during the treatment process,such as nausea,vomiting.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
mainland in China
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297242


Contacts
Contact: Yi Q Du, MD +86-13801993592 duyiqi@hotmail.com
Contact: Ai R Liu, MM +86-13701798230 13701798230@163.com

Sponsors and Collaborators
Changhai Hospital
Investigators
Principal Investigator: Zhao S Li, MD

Responsible Party: Zhaoshen Li, director of the Digestive Department, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03297242     History of Changes
Other Study ID Numbers: chbs230023
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhaoshen Li, Changhai Hospital:
Helicobacter Pylori eradication

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bismuth
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents