TOGAS

Helicobacter pylori is a bacteria that infects the stomach lining of up to 50% of the world’s population. It has been recognised as a class I cancer-causing agent (i.e. carcinogen) since 1994. Several randomised controlled trials* have been performed, which show stomach cancer can be reduced by 40% if we effectively screen for and treat it.

Notably, it is also known to cause other common medical conditions, including;

• Low blood counts (anaemia)
• Irritation of the stomach lining (gastritis)
• Ulceration of the stomach or gut (peptic ulcer disease)

There have also been extensive epidemiological studies recently that suggest its implication in Alzheimer’s dementia and colon cancer.

Fortunately, testing and treatment for this bacteria is possible. However, it usually is only done in those who present with symptoms.

Lastly, It is important to note that not everyone infected with this bacteria will develop a medical problem associated with it. From previous studies, we know that most infected individuals develop inflammation in their stomach, 20% will develop stomach or gut ulcers, and 1% of people will develop gastric cancer.

*Randomised control trials are the highest quality of evidence in research

You are eligible to take part if you have received an invitation and fulfil the below criteria:

• Aged between 30–34 years old
• Have never been diagnosed or treated for Helicobacter pylori
• Have never had a major operation on your stomach

Reduce your risk of stomach cancer and other conditions

The direct benefit of participating in this study is that we will identify if you have the bacteria H. pylori. Identifying and treating this bacteria at a young age will reduce your risk of developing conditions such as inflammation of stomach ulcers and stomach cancer.

Reduce your risk of transmission to your family

Identifying and treating this bacteria before you start a family will indirectly reduce your risk of transmitting this infection to future generations, as this bacteria is typically believed to be transmitted from parent to child.

Cost-saving

Testing for this bacteria is currently only done for people who have symptoms. It can be costly to be tested and treated. The average cost of testing and treatment for this bacteria is approximately €360!* This study will cover all of these expenses.

*Prices based on (GP appointment – €60, UBT referral – €125, treatment – €100, repeat test to confirm treated – €75)

Positive impact on the community and guideline development

On a wider level, by participating in this study, you will help prove that screening for this bacteria at a population level is possible, with the potential for this to lead to a national screening programme.

It will not cost you anything to participate in this study. Our research team will perform the testing you require and if your result is positive, we will provide you with treatment and follow up you require.

In fact, participating in this trial could ultimately be cost saving see our ‘benefits of participating’ section to see how much testing normally costs.

If you are considering participating in the study and want to know what it involves, please see the steps below.

1. Respond to the invitation and arrange an appointment slot.

After you receive your invite, please e-mail, text or call us to express interest. The team will ask you some simple questions and arrange a time for a blood appointment slot that suits you. We can offer early morning, evening and occasional weekend appointments.

2. Read & sign the documents we send you.

As this is a study, we want to give you as much information as possible so you can make an informed decision. This involves us sending you documents and a consent form to read through before your appointment.

3. Arrive for your appointment.

On the day of your test, a study team member will meet you, answer any questions you have from the documents we sent you and take your blood. This whole process will take approximately 15-20minutes.

4. Get a copy of your results.

We will send you a copy of your results 1-2 weeks after your test. If your test returns positive, we will be in touch to arrange follow-up and treatment.

Blood testing can be daunting experience for some people. If this is you, you are not alone. To ensure you have a positive experience we will have a team of skilled blood takers on hand who will use small needles and take the least amount of blood required to complete the test (1 vial). There are a lot of benefits to participating (see what is the benefit of participating in the study) and if you let us know on the day we will help guide you through the process.

Equally if you feel having your blood taken is stopping you taking part in the study please let us know and we could potentially offer you an alternative test without needles. The team can be reached at [email protected] or the study line at 087 482 8941.

No! Taking bloods and filling out the questionnaire will only take approximately 15 minutes.  There is a dedicated team of healthcare professionals to take bloods for the study so you won’t have a lengthy waiting process. If your blood test result is positive, you will need a second test called a breath test, which will take approximately 30 minutes.

Treatment is a 10-14 day course of antibiotics and an acid suppression tablet, e.g. Nexium.

In 90% of people, this will be enough to get rid of the bacteria, less than 10% of people may need a 2nd course of antibiotics.

Testing will be performed by the research team in the Beacon Hospital. Further details on the location will be provided by the study team in advance of your appointment. Please see here for instructions on how to get to the Beacon by car, luas or bus.

Be assured that all personal data will be treated with care, in compliance with GDPR and the Health Research Regulations 2018. Data will be stored until February 2031, at which point they will be destroyed. The purpose of keeping data until this point is to comply with EU regulations. We will publish the results of the project both in medical journals and on study-related websites, however, there will be no way individual results can be traced back to you.

Unfortunately, we can only include participants in the relevant age range of 30–34 years (up to day before 35^th birthday).

If you are outside the age range and want to get tested you will need to visit your GP for a referral. Unfortunately, you will have to pay for this yourself as the study only funds a specific group.

The Irish research team includes;

• Professor Colm O’Morain, National Clinical Lead for Gastroenterology, HSE, International expert in Helicobacter Pylori, Professor Emeritus Trinity College Dublin.
• Dr Orlaith Kelly, Consultant Gastroenterologist Connolly Hospital, Senior Clinical lecturer RCSI.
• Dr Charlene Deane, Gastroenterology Specialist Registrar, Clinical Research Registrar.
• Ana McKiernan, Clinical Research Associate
• Maureen Moore, Research Nurse

If you wish to participate or have unanswered questions, please contact us at [email protected] or contact the study line at 087-482 8941. When you contact the team we will schedule a time to call you to go through a few questions. If you are eligible, we will schedule you a blood taking slot at a time that works best for you and send you further short information documents through your preferred means of contact i.e. email/post.