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Contact Information:

Miss Sara Mancell
+44 (0)203 299 4434
sara.mancell@nhs.net


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Be Part of Research - Trial Details - Medium-chain fat supplementation and growth in infants with biliary atresia: a feasibility study
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Medium-chain fat supplementation and growth in infants with biliary atresia: a feasibility study

Not Recruiting

Open to: All Genders

Age: Child

London

Medical Conditions

Biliary atresia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Biliary atresia (BA) is a rare liver disease of the bile ducts which results in many babies eventually needing a liver transplant. As bile from the bile ducts is needed to digest fat, babies with BA may not absorb enough fat and can become malnourished. Babies with biliary atresia are given medium-chain fat, a special fat made from coconut oil that can be absorbed even when there is no bile in the gut. Medium-chain fat is incorporated into specialist formula milk for children with liver disease. It can also be added separately to formula milk or to expressed breast milk as an oil. The aim of giving medium-chain fats is to provide an energy source so babies can grow. Even though medium-chain fats are used widely in the NHS there is no agreement on how much to give. Babies are given anywhere from 30% to 75% of their total fat intake as medium-chain fat with the remainder being regular fat. The aim is to carry out a future trial comparing growth and outcomes in babies receiving different amounts of medium-chain fats. To prepare for this trial the researchers will first carry out this study to test whether a future trial would be possible.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Jan 2023 04 Mar 2025

In this feasibility study, 30 babies with biliary atresia will have either low or high amounts of medium-chain fat for 6 weeks. This will be achieved by adding different oils to their formula milk, oils commonly used in the diet and in the NHS. Information on weight, intake and tolerance will be recorded. Caregivers will be asked about their experiences of being in the study through a questionnaire and interview.


Biliary atresia (BA) is a rare liver disease of the bile ducts which results in many babies eventually needing a liver transplant. As bile from the bile ducts is needed to digest fat, babies with BA may not absorb enough fat and can become malnourished. Babies with biliary atresia are given medium-chain fat, a special fat made from coconut oil that can be absorbed even when there is no bile in the gut. Medium-chain fat is incorporated into specialist formula milk for children with liver disease. It can also be added separately to formula milk or to expressed breast milk as an oil. The aim of giving medium-chain fats is to provide an energy source so babies can grow. Even though medium-chain fats are used widely in the NHS there is no agreement on how much to give. Babies are given anywhere from 30% to 75% of their total fat intake as medium-chain fat with the remainder being regular fat. The aim is to carry out a future trial comparing growth and outcomes in babies receiving different amounts of medium-chain fats. To prepare for this trial the researchers will first carry out this study to test whether a future trial would be possible.

Who can participate?
Infants with biliary atresia who have had a kasai portoenterostomy performed at King’s College Hospital NHS Foundation Trust at or before 12 weeks of age will be invited to participate. Infants will not be included if they have had previous liver surgery, have a severe cardiac illness, were born before 32 weeks’ gestation or have planned follow-up outside the United Kingdom.

You can take part if:



You may not be able to take part if:


1. Previous hepatobiliary surgery2. Severe cardiac illness3. Born before a gestational age of 32 weeks4. Not for follow-up in the United Kingdom


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Kings College Hospital
    Mapother House De Crespigny Park Denmark Hill
    London
    SE5 8AB

There may be no direct benefit to participants but the aim is to help babies who are diagnosed with biliary atresia in the future. Some participants might find it a benefit to have a dedicated feeding diary for recording formula milk intake information. Participants might also find it a benefit to have regular contact with the researcher who is a dietitian and will provide additional support with feeding. There are no anticipated risks of participating.

Miss Sara Mancell
+44 (0)203 299 4434
sara.mancell@nhs.net



The study is sponsored by King's College London and funded by NIHR Academy; Grant Codes: NIHR302152.



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What will you do next?
Read full details for Trial ID: ISRCTN81936667

Or CPMS 54463

Last updated 11 April 2025

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