Reinfection After Eradication of Helicobacter Pylori Infection

Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Clinical Trial

— RAEHPI  

Official title:

Reinfection After Eradication of Helicobacter Pylori Infection in Adult :A National Multicentre Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02674802
• Other study ID #: Affiliated Hospital of NCU
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2016
• Last updated: February 3, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2016
• Source: The First Affiliated Hospital of Nanchang University
• Contact: Ying Huang, MD
• Phone: 15270953973
• Email: 497514037[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter Pylori Infection	Retrospective study	six months	Yes
Primary	Helicobacter Pylori Infection	Prospective study	After regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months	Yes

External Links

•   the First Affiliated Hospital of Nanchang University