Reinfection After Eradication of Helicobacter Pylori Infection

NCT ID: NCT02674802

Last Updated: 2016-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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

Study Groups

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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.

No interventions assigned to this group

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 .

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Lingyu Luo

Physician-in-charge

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nonghua Lv, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of Nanchang University

Locations

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Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Huang, MD

Role: CONTACT

15270953973

Yong Xie, MD

Role: CONTACT

13177893950

Facility Contacts

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Nonghua Lv, MD

Role: primary

13707086809

Kunhe Zhang, MD

Role: backup

13007202818

References

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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.

Reference Type BACKGROUND
PMID: 22491499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20302589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23567104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22350696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10372933 (View on PubMed)

Related Links

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http://www.cdyfy.com/

the First Affiliated Hospital of Nanchang University

Other Identifiers

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Affiliated Hospital of NCU

Identifier Type: -

Identifier Source: org_study_id

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