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Reinfection After Eradication of Helicobacter Pylori Infection (RAEHPI)

Primary Purpose

Bacterial Infection Due to Helicobacter Pylori (H. Pylori), Eradication Therapy of Helicobacter Pylori, Detection of Helicobacter Pylori

Status
Unknown status
Phase
Locations
China
Study Type
Observational
Intervention
Sponsored by
The First Affiliated Hospital of Nanchang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Bacterial Infection Due to Helicobacter Pylori (H. Pylori) focused on measuring Reinfection, Eradication therapy, C-urea breath test, Helicobacter Pylori

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-1、Retrospective study：

  1. Received regular eradication therapy, 4 to 8 weeks after drug withdrawal , detected of helicobacter pylori and the results were negative
  2. Eradication program and original disease is unlimited
  3. Without any eradication therapyof Hp during the treatment and detection again
  4. before the detection has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks.

2、Prospective study

  1. Infected with H. pylori that detected by C-UBT
  2. With out alimentary tract hemorrhage,ulceration and complications of eradication
  3. Eradication program and original disease is unlimited

Exclusion Criteria:

  1. Pregnancy or breast-feeding women
  2. With the major disease which would influence the research such as liver disease, heart disease, kidney disease, malignant tumor and alcohol poisoning
  3. Participated in other drug research in the past three months
  4. The patient can't express himself correctly such as mental illness and severe neurosis and can't cooperation this test

Sites / Locations

  • Affiliated Hospital of Nanchang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Retrospective study

Prospective study

Arm Description

People who has successfully eradicated helicobacter pylori more than six months detected helicobacter pylori by the C-urea breath test in order to evaluate the reinfection.

People who has infected helicobacter pylori received regular eradication therapy after the 4 weeks, 8 weeks and 6 months detected helicobacter pylori by the C-urea breath test in order to prospect the reinfection .

Outcomes

Primary Outcome Measures

Helicobacter Pylori Infection
Retrospective study
Helicobacter Pylori Infection
Prospective study

Secondary Outcome Measures

Full Information

First Posted
February 2, 2016
Last Updated
February 3, 2016
Sponsor
The First Affiliated Hospital of Nanchang University
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1. Study Identification

Unique Protocol Identification Number
NCT02674802
Brief Title
Reinfection After Eradication of Helicobacter Pylori Infection
Acronym
RAEHPI
Official Title
Reinfection After Eradication of Helicobacter Pylori Infection in Adult :A National Multicentre Study
Study Type
Observational

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Nanchang University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Helicobacter pylori is closely related with gastritis, peptic ulcer, gastric cancer and gastric MALT lymphoma, and it may participate in a variety of parenteral diseases. Infection rates of Helicobacter pylori is still high, so effectively eradication is necessary. At present, the eradication therapy has achieved very good curative effect. However, relapse after eradication is unoptimistic. This study has made an analysis for reinfection after eradication of Helicobacter pylori Infection include the retrospective and prospective studies, aims to explore the epidemiological data and related risk factors of Hp reinfection in China.
Detailed Description
In the retrospective study,we choose the people received regular eradication therapy, successfully eradicated helicobacter pylori more than six months, but 4 to 8 weeks after drug withdrawal ,the detection result of helicobacter pylori were negative to ensure that the results of the study is the reinfection, not residual. Even more noteworthy is during the treatment and detection again, the patients must not received any eradication therapy of Hp. What's more , before the detection, they also has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks to prevent affecting the accuracy of the results. At the same time, we also investigated the patient's general situation, conomic conditions, living conditions, personal health and lifestyle to explore related risk factors of Hp reinfection in China. In the prospective study, we detected Hp by C-UBT after regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months to prospect the reinfection of Hp.It also can make up the defects of retrospective study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection Due to Helicobacter Pylori (H. Pylori), Eradication Therapy of Helicobacter Pylori, Detection of Helicobacter Pylori
Keywords
Reinfection, Eradication therapy, C-urea breath test, Helicobacter Pylori

7. Study Design

Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retrospective study
Arm Description
People who has successfully eradicated helicobacter pylori more than six months detected helicobacter pylori by the C-urea breath test in order to evaluate the reinfection.
Arm Title
Prospective study
Arm Description
People who has infected helicobacter pylori received regular eradication therapy after the 4 weeks, 8 weeks and 6 months detected helicobacter pylori by the C-urea breath test in order to prospect the reinfection .
Primary Outcome Measure Information:
Title
Helicobacter Pylori Infection
Description
Retrospective study
Time Frame
six months
Title
Helicobacter Pylori Infection
Description
Prospective study
Time Frame
After regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -1、Retrospective study： Received regular eradication therapy, 4 to 8 weeks after drug withdrawal , detected of helicobacter pylori and the results were negative Eradication program and original disease is unlimited Without any eradication therapyof Hp during the treatment and detection again before the detection has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks. 2、Prospective study Infected with H. pylori that detected by C-UBT With out alimentary tract hemorrhage,ulceration and complications of eradication Eradication program and original disease is unlimited Exclusion Criteria: Pregnancy or breast-feeding women With the major disease which would influence the research such as liver disease, heart disease, kidney disease, malignant tumor and alcohol poisoning Participated in other drug research in the past three months The patient can't express himself correctly such as mental illness and severe neurosis and can't cooperation this test
Study Population Description
In the retrospective study,people who has infected helicobacter pylori and successfully eradicated it more than six months detected helicobacter pylori by the C-urea breath test in order to evaluate the reinfection In the prospective study,people who has infected helicobacter pylori received regular eradication therapy after the 4 weeks, 8 weeks and 6 months detected helicobacter pylori by the C-urea breath test in order to prospect the reinfection
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Huang, MD
Phone
15270953973
Email
497514037@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Xie, MD
Phone
13177893950
Email
xieyong_med@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nonghua Lv, MD
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nonghua Lv, MD
Phone
13707086809
Email
lunonghua@163.com
First Name & Middle Initial & Last Name & Degree
Kunhe Zhang, MD
Phone
13007202818
Email
393467260@qq.com
First Name & Middle Initial & Last Name & Degree
Nonghua Lv, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22491499
Citation
Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
Results Reference
background
PubMed Identifier
20302589
Citation
Silva FM, Navarro-Rodriguez T, Barbuti RC, Mattar R, Hashimoto CL, Eisig JN. Helicobacter pylori reinfection in Brazilian patients with peptic ulcer disease: a 5-year follow-up. Helicobacter. 2010 Feb;15(1):46-52. doi: 10.1111/j.1523-5378.2009.00734.x.
Results Reference
background
PubMed Identifier
23567104
Citation
Benajah DA, Lahbabi M, Alaoui S, El Rhazi K, El Abkari M, Nejjari C, Amarti A, Bennani B, Mahmoud M, Ibrahimi SA. Prevalence of Helicobacter pylori and its recurrence after successful eradication in a developing nation (Morocco). Clin Res Hepatol Gastroenterol. 2013 Nov;37(5):519-26. doi: 10.1016/j.clinre.2013.02.003. Epub 2013 Apr 6.
Results Reference
background
PubMed Identifier
22350696
Citation
Take S, Mizuno M, Ishiki K, Imada T, Okuno T, Yoshida T, Yokota K, Oguma K, Kita M, Okada H, Yamamoto K. Reinfection rate of Helicobacter pylori after eradication treatment: a long-term prospective study in Japan. J Gastroenterol. 2012 Jun;47(6):641-6. doi: 10.1007/s00535-012-0536-9. Epub 2012 Feb 17.
Results Reference
background
PubMed Identifier
10372933
Citation
Archimandritis A, Balatsos V, Delis V, Manika Z, Skandalis N. "Reappearance" of Helicobacter pylori after eradication: implications on duodenal ulcer recurrence: a prospective 6 year study. J Clin Gastroenterol. 1999 Jun;28(4):345-7. doi: 10.1097/00004836-199906000-00012.
Results Reference
background
Links:
URL
http://www.cdyfy.com/
Description
the First Affiliated Hospital of Nanchang University

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Reinfection After Eradication of Helicobacter Pylori Infection

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