Bacterial Infection Due to Helicobacter Pylori (H. Pylori)RAEHPINCT02674802
Reinfection After Eradication of Helicobacter Pylori Infection
An observational study of Bacterial Infection Due to Helicobacter Pylori (H. Pylori) and Eradication Therapy of Helicobacter Pylori, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bacterial Infection Due to Helicobacter Pylori (H. Pylori), Eradication Therapy of Helicobacter Pylori, Detection of Helicobacter Pylori
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Sep 2016
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- -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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Nonghua Lv, MD, 13707086809, lunonghua@163.com
Kunhe Zhang, MD, 13007202818, 393467260@qq.com
About this study
Official title: Reinfection After Eradication of Helicobacter Pylori Infection in Adult :A National Multicentre Study
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.
Read the 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.
- Conditions
- 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
- Medical subject headings
- Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter Pylori Infection
Retrospective study
Measured: six months
Helicobacter Pylori Infection
Prospective study
Measured: After regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bacterial Infection Due to Helicobacter Pylori (H. Pylori)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingyu Luo, The First Affiliated Hospital of Nanchang University
- Investigators
- Nonghua Lv, MD, Study chair, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674802
- Sponsor's protocol ID
- Affiliated Hospital of NCU
- Acronym
- RAEHPI
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22491499Silva 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.
PubMed 20302589Benajah 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.
PubMed 23567104Take 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.
PubMed 22350696Archimandritis 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.
PubMed 10372933