Helicobacter Pylori Eradication
| ISRCTN | ISRCTN36321686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36321686 |
| Secondary identifying numbers | 210247 |
- Submission date
- 23/11/2014
- Registration date
- 10/12/2014
- Last edited
- 10/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Helicobacter pylori (HP) is a bacteria that can infect the stomach lining and duodenum (first part of the intestine). Once infected, unless treated, a person is infected for life. Most people have no symptoms (asymptomatic). However, it can cause ulcers, indigestion, nausea and vomiting, extreme tiredness (fatigue) and tarry stools. Over time,, it can also increase the risk of stomach cancer. Patients with symptoms can be offered eradication therapy, which consists of a combination of antibiotics. HP eradication is still a problem, however, as desired levels of treatment have not been achieved yet. Here, we want to find out whether the success rate of HP eradication is lower in a country where the rate of HP infection is high and is there any benefit to treating asymptomatic HP-positive (infected) partners at the same time as symptomatic HP-positive patients.
Who can participate?
Adult symptomatic HP-positive patients and their asymptomatic HP-positive partners.
What does the study involve?
The patients are randomized into two groups. Those in group 1 are treated for HP infection and so are their partners. Those in group 2 are also treated but their partners are not. The treated offered to all participants is a combination therapy of levofloxacin 500 mg daily, amoxicillin 1g b.i.d and lansoprazole 30 mg b.i.d (LAL) for ten days. The presence of HP bacteria is then tested for by a stool antigen test six weeks later.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Recep Tayyip Erdoğan (RTE) University, Gastroenterology Polyclinic (Turkey)
When is the study starting and how long is it expected to run for?
January 2013 to November 2014
Who is funding the study?
Recep Tayyip Erdoğan (RTE) University, Gastroenterology Polyclinic (Turkey)
Who is the main contact?
Dr Halil Rakici
halilrakici59@hotmail.com
Contact information
Scientific
Recep Tayyip Erdogan University
Rize
53100
Türkiye
| Phone | +905326869760 |
|---|---|
| halilrakici59@hotmail.com |
Study information
| Study design | Single-centre, prospective, controlled. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Is There Any Advantage of Treating Partners in Helicobacter Pylori Eradication? |
| Study objectives | Effects of partners and reinfection on H.pylori eradication were studied. |
| Ethics approval(s) | Ethics Committee RTE University , 17/10/2014, ref. 2014/132 |
| Health condition(s) or problem(s) studied | Helicobacter pylori (HP) infection |
| Intervention | The participants were randomised into two groups: Group 1: HP-positive patients and HP-positive partners were treated with levofloxacin 500 mg daily, amoxicillin 1g b.i.d and lansoprazole 30 mg b.i.d (LAL) for ten days. Group 2: Only the HP-positive patients were treated with levofloxacin 500 mg daily, amoxicillin 1g b.i.d and lansoprazole 30 mg b.i.d (LAL) for ten days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 1. Levofloxacin 2. Amoxicillin 3. Lansoprazole |
| Primary outcome measure | Eradication success rate |
| Secondary outcome measures | Re-infection rate between partners |
| Overall study start date | 01/01/2013 |
| Completion date | 30/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 206 |
| Key inclusion criteria | Helicobacter pylori positive patients and their partners |
| Key exclusion criteria | People who are Helicobacter pylori negative |
| Date of first enrolment | 13/01/2013 |
| Date of final enrolment | 31/10/2014 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
53100
Türkiye
Sponsor information
Hospital/treatment centre
Islampasa Mah
Rize
53100
Türkiye
| Phone | +905326869760 |
|---|---|
| halilrakici59@hotmail.com | |
"ROR" |
https://ror.org/0468j1635 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2015 | 10/05/2021 | Yes | No |
Editorial Notes
10/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
