Helicobacter Pylori Eradication

ISRCTN	ISRCTN36321686
DOI	https://doi.org/10.1186/ISRCTN36321686
Protocol serial number	210247
Sponsor	Recep Tayyip Erdogan University
Funder	Recep Tayyip Erdogan University (Turkey)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Halil Rakici
Scientific

Recep Tayyip Erdogan University
Rize
53100
Türkiye

Phone	+905326869760
Email	halilrakici59@hotmail.com

Study information

Primary study design	Interventional
Study design	Single-centre, prospective, controlled.
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	1. Levofloxacin 2. Amoxicillin 3. Lansoprazole
Primary outcome measure(s)	Eradication success rate
Key secondary outcome measure(s)	Re-infection rate between partners
Completion date	30/11/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Recep Tayyip Erdoğan (RTE) University, Gastroenterology Polyclinic

Rize
53100
Türkiye

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.