When babies experience severe symptoms of reflux, it is called Gastro-oesophageal reflux disease, or ‘GOR’ for short. Simple things like keeping the baby upright during feeds and for 20minutes afterwards or using products that thicken the feeds can be useful. But, when things are more severe, health professionals often use medicines including omeprazole. Omeprazole is a medicine that is commonly prescribed for babies who are experiencing reflux symptoms, but it’s not clear how effective this is in treating the symptoms. To answer this, a large research study is needed.  

Omeprazole helps to reduce the acid in the stomach which may help with the babies’ symptoms. But it’s not clear whether these medicines work or not and we don’t want to use these medicines unnecessarily as some studies have shown they might increase the risk of infection or affect bone strength.  

In the OTTER study we are comparing the omeprazole medicine with a placebo. The placebo is a liquid that looks and tastes the same as omeprazole but it doesn’t have any real medicine in it. Half of the babies in the study will take omeprazole and half will take the placebo.  

The purpose of the OTTER study is to find out if omeprazole improves reflux symptoms. To answer this, we will ask parents to complete questionnaires to tell us about their baby’s symptoms. The study will also look at other things like feeding and growth, infections, bone fractures, any hospital admissions, and quality of life for you and your baby. 

Your baby has been invited to take part in this study because they are experiencing reflux symptoms, your doctor has tried other ways to improve these symptoms and is now considering prescribing a medicine. We are inviting babies, like yours, to take part from hospitals and GP surgeries around the UK. 

It is up to you whether or not your baby takes part in the study. Even if you agree now, you are free to withdraw your baby at a later date if you wish. We will talk to you about the study and answer any questions you may have. If you agree to take part, we will ask you to sign a consent form. 

If your baby is experiencing reflux and previous treatment hasn’t worked, you might be given information about the OTTER study.  

If your baby is eligible you will be asked to complete a consent form. You will also be asked a few questions about you and your baby. 

Your baby will be given omeprazole or placebo, to take everyday for 4 weeks. 

After two weeks the research team will call you to see how you and your baby is doing. We will continue to contact you every two weeks to find out if you have needed to access additional health services for your baby. 

At 1 and 6 months after your baby is enrolled we will send you a questionnaire. This will ask about your baby’s reflux symptoms and general health. These can be completed online or via post. 

We don’t know how effective omeprazole is, so we don't know whether either of the trial treatments will directly benefit your baby.   

Although you and your baby may not directly benefit from taking part, the study will help health professionals understand how to treat reflux symptoms better in the future, and therefore your baby’s participation could help babies and parents in the future.   

We know how stressful it can be when your baby is unwell, and many parents have told us how much it helps to feel supported. Someone from our research team will give you a call about two weeks after your baby joins the study just to check in and see how you're both doing, which you may find beneficial.  

As a small thank you and token of our appreciation, you will receive a £20 high-street shopping voucher along with your 4week questionnaire.   

Omeprazole is often given to babies with reflux symptoms and is thought to be safe, but it may not be as effective as previously thought and could increase the risk infections or affect bone strength. That’s why a big study like this is needed.  

Omeprazole is approved to be used for babies over one month of age who have reflux symptoms. Like any medicine, omeprazole can have side effects for some individuals. All of the known side effects can be found here.

The most common side effects (affecting 1in 10 people), relate to effects on the stomach or gut, including diarrhoea, tummy ache, feeling or being sick. Headaches and benign stomach polyps can also affect 1 in 10 people.   

Uncommon and rare side effects are listed in the online information linked above. 

If you have concerns or questions about any aspect of this study, you should ask to speak to the local care team. Their contact details can be found at the end of the Patient information sheet they handed out to you.    

If any questions remain, you can contact the trial coordinating centre using the Contact Us page.

If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure via your local Patient Advisory and Liaison Service (PALS).  

In the event that something does go wrong, and you are harmed during the trial, there are no special compensation arrangements. If you are harmed and this is due to someone’s negligence, then you have grounds for a legal action for compensation, but you may have to pay your legal costs. The normal NHS complaints mechanism will still be available to you. 

You are free to withdraw your baby at any time, without giving any reason, and without you or your baby’s legal rights being affected. If you would like to withdraw your baby, contact your local care team and they can organise this. Their contact details are at the end of this information sheet. If you withdraw, the information collected will not be erased and this information may still be used in the project analysis. 

We may get new information about reflux symptoms or the omeprazole medicine during the study. If this happens the research doctor will tell you about this new information and discuss whether your baby should continue in the study. If you decide for your baby not to carry on, your research doctor will arrange for their care to continue as normal. If you decide for them to continue in the study, you may ask you to sign a new Informed Consent Form. 

When the study ends, your baby’s care will continue as normal. If your baby withdraws from the study, we will need to keep and use the data collected up to withdrawal. At the end of the study the results will be published in scientific medical journals and presented at conferences. You will not be identified in any publication. We will send you a newsletter with a summary of the study findings, unless you ask us not to. We will also share our findings with parent groups and social media. 

We will need to use information from you, your GP and your healthcare team for this research project.   

This information will include your initials, NHS number, name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly.   

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  

University Hospital Southampton NHS Foundation Trust is the sponsor of this research. The sponsor is responsible for looking after your information. We will share your information related to this research project with the following types of organisations:   

• Trial coordinating centre (NCTU at the University of Nottingham)   

• If you give consent, your mobile number will be shared with a text messaging service (Esendex and its subprocessors)  

• If your baby’s medicine needs to be posted to your home, your address will be shared with the medicine supplier   

• Regulatory Authorities may need to access your data for auditing purposes  

We will keep all information about you safe and secure by:  

• Following and adhering to the laws relating to General Data Protection Regulation (GDPR)  

• Having strict access controls on our electronic systems  

• Deleting your personal data (as outlined in this information sheet) when it is no longer required  

• Keeping the details we have to contact you separate from the study data  

 Your data will not be shared outside the UK. 

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.  

We will keep your study/study data for a maximum of 25 years. The study data will then be fully anonymised and securely archived or destroyed.