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Status unknownNCT03297242Updated Dec 7, 2017

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

An observational study in Helicobacter Pylori Infection, sponsored by Changhai Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by Changhai Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Helicobacter Pylori Infection

Keywords

  • Helicobacter Pylori eradication
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

mainland in China

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

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
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. urea breath test

    if urea breath test is negative,it means H pylori eradicated successfully

    Time frame: 4-6 weeks after the quadruple therapy

Secondary outcomes

  1. adverse effects

    adverse effects mean the new symptoms during the treatment process,such as nausea,vomiting.

    Time frame: 1month

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03297242
Lead sponsor
Changhai Hospital
Responsible party
Zhaoshen Li (director of the Digestive Department, Changhai Hospital) — Principal investigator
First posted
Sep 29, 2017
Start date
Dec 2017 (estimated)
Primary completion
Sep 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Dec 7, 2017

Study contacts

Yi Q Du, MD
Contact
duyiqi@hotmail.com
+86-13801993592
Ai R Liu, MM
Contact
13701798230@163.com
+86-13701798230
Zhao S Li, MD
principal investigator

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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