Condition category
Infections and Infestations
Date applied
23/11/2014
Date assigned
10/12/2014
Last edited
11/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Halil Rakici

ORCID ID

Contact details

Recep Tayyip Erdogan University
Rize
53100
Turkey
+905326869760
halilrakici59@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

210247

Study information

Scientific title

Is There Any Advantage of Treating Partners in Helicobacter Pylori Eradication?

Acronym

Study hypothesis

Effects of partners and reinfection on H.pylori eradication were studied.

Ethics approval

Ethics Committee RTE University , 17/10/2014, ref. 2014/132

Study design

Single-centre, prospective, controlled.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

1. Levofloxacin
2. Amoxicillin
3. Lansoprazole

Primary outcome measures

Eradication success rate

Secondary outcome measures

Re-infection rate between partners

Overall trial start date

01/01/2013

Overall trial end date

30/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Helicobacter pylori positive patients and their partners

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

People who are Helicobacter pylori negative

Recruitment start date

13/01/2013

Recruitment end date

31/10/2014

Locations

Countries of recruitment

Turkey

Trial participating centre

Recep Tayyip Erdoğan (RTE) University, Gastroenterology Polyclinic
Rize
53100
Turkey

Sponsor information

Organisation

Recep Tayyip Erdogan University

Sponsor details

Islampasa Mah
Rize
53100
Turkey
+905326869760
halilrakici59@hotmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Recep Tayyip Erdogan University (Turkey)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes