An introduction to the OTTER Study
OTTER stands for Omeprazole for Treatment of Term and preterm infants with gastro-oEsophageal Reflux. It is a study to find out if a medicine (Omeprazole), which is given to babies with gastro-oesophageal reflux, is effective at reducing their symptoms.
To find out more about the study you can watch this animated video:
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In this video, the Chief Investigators of the study, Mark and Deepthi, talk about reflux:
How does OTTER work?
Gastro-oesophageal reflux (GOR) is when milk and acid come back up from the stomach after feeds, rather than moving on to the rest of the bowel to be digested. It is very common in babies. Mild symptoms of reflux, such as crying or being a little sick, are experienced by most babies at some point, often do not need any treatment and get better on their own over the first few months. However, in some babies, symptoms can be more severe with pain, discomfort, screaming and poor weight gain.
When symptoms are more severe, health professionals often use medicines, like omeprazole, that reduce stomach acid to manage symptoms. Although these medicines have been used for a while, it is not clear if they are effective. Using these medicines unnecessarily may be harmful to babies, with some studies suggesting long-term effects like infections and broken bones.
If the parent/caregiver gives consent for their baby to participate, they will be prescribed either omeprazole or a ‘placebo’ that looks the same but has no medicine in it. Neither the parents nor healthcare professionals can choose or know which treatment the baby will have and instead, this will be selected at random by a computer, with babies having a 50/50 chance of receiving either treatment. This is to prevent healthcare professionals and parents being influenced by knowing what treatment their baby had when assessing their symptoms.
Babies will be treated with omeprazole or placebo for 4 weeks, after which we will ask parents to complete an online questionnaire about their baby’s symptoms. Babies will also be followed up for 6 months to look for possible longer-term effects of omeprazole and GOR on growth, infections, bone health and quality of life for parents/carers. Parents have suggested we should collect these outcomes by sending a text message once a fortnight to ask them if their baby has experienced any of these. We will also talk to parents and health professionals in-depth about their experiences of being in the study.
We will be including babies who were born prematurely and those born at term. In total we will be including around 500 babies.
Recruitment
We expect OTTER to start recruiting at the end of August 2026.