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
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.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0822
Date of REC Opinion
21 Nov 2022
REC opinion
Favourable Opinion