MCT Feasibility Study v1
Research type
Research Study
Full title
Medium-chain triglyceride supplementation and growth in infants with biliary atresia: a feasibility study
IRAS ID
311670
Contact name
Sara Mancell
Contact email
Sponsor organisation
Kings College London
ISRCTN Number
ISRCTN81936667
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Summary of Research
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. To help prevent malnutrition and help babies to grow, medium-chain fat is given as an energy source. Medium-chain fat is a special fat that can be absorbed even when there is no bile available. Babies are given anywhere from 30% to 75% of their total fat intake as medium-chain fat with the remainder being regular fat.
What is the problem?
Medium-chain fats are used widely in the NHS but there is no agreement on how much to give.Has research been done?
Limited research has focused on how medium-chain fats affect fat absorption and growth.What do we want to know?
How does the amount of medium-chain fat given to babies with BA affect growth and outcomes?What is our study?
We aim to carry out a future trial comparing growth and outcomes in babies receiving different amounts of medium-chain fat. To prepare for the future trial we will first carry out this feasibility study. The feasibility study will test the best way to carry out the future trial. In this feasibility study, 30 babies with BA will have either low or high amounts of medium-chain fat for six 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.How will patients benefit?
Through better understanding medium-chain fats we could improve the growth of babies with BA and help avoid later medical complications.Summary of Results
What is the background for the study?
This research focused on a special fat given to babies with biliary atresia. Biliary atresia is a rare liver disease that presents in the first few weeks of life. Bile ducts usually transport bile from the liver to the gut. However, babies with biliary atresia have blocked or absent bile ducts. This means that bile cannot flow to the gut. Instead, bile builds up and causes liver damage. The result is that most babies with biliary atresia will eventually need a liver transplant.Bile is needed in the gut to help us absorb fat. Therefore, babies with biliary atresia do not absorb fat very well and many become malnourished. A special fat called medium-chain fat (or medium-chain triglycerides) is given to babies with biliary atresia. This fat can be absorbed even when there is no bile in the gut. The aim of giving medium-chain fat is to provide an energy source so babies can grow. This is especially important if they go on to need a liver transplant.
What is the problem?
Medium-chain fats are used widely in the NHS and around the world but 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. Very little research has been done on how different amounts of medium-chain fats affect growth, nutritional status and outcome.What was the aim of our study?
Our aim was to carry out a feasibility study to test whether a future trial would be possible. We wanted to know how many parents would consent to take part in the study, how many would complete it and how many babies would have the intervention consistently. We were also interested in whether parents would find the study acceptable.What did the study involve?
After diagnosis with biliary atresia, babies either received low or high amounts of medium-chain fats. The group they were assigned to (low or high) was chosen at random. The study was double blind meaning that parents and the researcher were not aware of which group babies were in. Parents were given a recipe for either low or high amounts of medium-chain fats. The recipe for the low group involved adding safflower oil (regular fat) to the baby’s specialist formula milk. The recipe for the high group involved adding refined coconut oil (medium-chain fat) to the baby’s specialist formula milk. Parents were encouraged to continue offering breastmilk during the study. During the five-week study we measured babies’ growth, milk intake, gastrointestinal symptoms, vitamin levels and liver function. At the end of the study parents were asked about the acceptability of the study through a questionnaire and interview.What were the findings?
We recruited 30 babies (18 male, 12 female) with biliary atresia between January 2023 and March 2025. The parents of 30/34 (88%) babies provided consent for their baby to take part and 25/30 (83%) completed the study. There were 21/27 (78%) babies who consistently had the oil added to their formula milk during the study. All parents agreed that the study was acceptable. One significant finding was that babies in the low group had a higher intake of energy than the high group. Although they had more energy, the low group did not have better growth than the high group. There were no differences in growth, feeding tolerance, vitamin levels or liver function between babies having low or high amounts of medium-chain fats.What were the conclusions from this study?
Although this was a feasibility study, it is the largest trial of medium-chain fats to date in babies with biliary atresia. Recruitment to the study was high and parents found the study acceptable. The finding that babies having low amounts of medium-chain fat had a higher intake of energy but did not have better growth is novel. Babies in the low group had lower amounts of special fat and may have compensated for this by drinking more formula milk.What will happen next?
We have shown that a trial comparing low and high amounts of medium-chain fats was feasible and acceptable to parents. A large scale, double-blind randomised controlled trial on medium-chain fats in biliary atresia should now be carried out.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0822
Date of REC Opinion
21 Nov 2022
REC opinion
Favourable Opinion