NCT02674802

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

February 2, 2016

Last Update Submit

February 3, 2016

Conditions

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

Keywords

ReinfectionEradication therapyC-urea breath testHelicobacter Pylori

Outcome Measures

Primary Outcomes (2)

  • Helicobacter Pylori Infection

    Retrospective study

    six months

  • Helicobacter Pylori Infection

    Prospective study

    After regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months

Study Arms (2)

Retrospective study

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.

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 .

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 、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.
  • 、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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22491499BACKGROUND

  • 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.

    PMID: 20302589BACKGROUND

  • 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.

    PMID: 23567104BACKGROUND

  • 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.

    PMID: 22350696BACKGROUND

  • 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.

    PMID: 10372933BACKGROUND

Related Links

MeSH Terms

Conditions

Reinfection

Condition Hierarchy (Ancestors)

RecurrenceDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nonghua Lv, MD

    The First Affiliated Hospital of Nanchang University

    STUDY CHAIR

Central Study Contacts

Ying Huang, MD

CONTACT

15270953973497514037@qq.com

Yong Xie, MD

CONTACT

13177893950xieyong_med@163.com

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician-in-charge

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 4, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

CN(1)