Medium-chain fat supplementation and growth in infants with biliary atresia: a feasibility study

Medium-chain triglyceride supplementation and growth in infants with biliary atresia: a feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81936667

Enrollment

Registered

2023-01-23

Start date

2023-01-30

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary atresia Digestive System

Interventions

Design This study will be a feasibility study. The purpose will be to determine whether it would be acceptable and achievable to carry out a future study on how different amounts (concentrations) of m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Biliary atresia diagnosis 2. Kasai portoenterostomy procedure performed at King's College Hospital at or before 12 weeks of age

Exclusion criteria

Exclusion criteria: 1. Previous hepatobiliary surgery 2. Severe cardiac illness 3. Born before a gestational age of 32 weeks 4. Not for follow-up in the United Kingdom

Design outcomes

Primary

Measure	Time frame
1. Recruitment is assessed by reporting the proportion of eligible patients recruited overall and the flow of participants over time 2. Retention rate is the proportion of randomised participants retained for the study’s duration 3. Fidelity is measured using the daily feeding diary where caregivers indicate whether the formula milk was given as per protocol 4. Acceptability is measured using an acceptability questionnaire and interview at 6 weeks post kasai portoenterostomy	—

Measure

Time frame

1. Recruitment is assessed by reporting the proportion of eligible patients recruited overall and the flow of participants over time 2. Retention rate is the proportion of randomised participants retained for the study’s duration 3. Fidelity is measured using the daily feeding diary where caregivers indicate whether the formula milk was given as per protocol 4. Acceptability is measured using an acceptability questionnaire and interview at 6 weeks post kasai portoenterostomy

—

Secondary

Measure	Time frame
1. Weight is measured in kg using class III clinical electronic scales at baseline and 1, 2, 3, 4, 5 and 6 weeks post kasai portoenterostomy and converted to age- and sex-adjusted z-scores (WHO, 2009) 2. Length is measured in cm using a recumbent length board at baseline and 6 weeks and converted to age- and sex-adjusted z-scores (WHO, 2009) 3. Head circumference is measured in cm using a disposable paper tape measure at baseline and 6 weeks and converted to age- and sex-adjusted z-scores (WHO, 2009) 4. Mid upper arm circumference is measured in cm using a disposable paper tape measure at baseline and 6 weeks 5. Formula milk intake (ml/kg/day) is measured using the feeding diary over the 6-week period 6. Medium-chain triglyceride intake (g/kg/day) is measured using the feeding diary over the 6-week period 7. Feeding tolerance is measured using the Infant Gastrointestinal Symptom Questionnaire (IGSQ) at baseline and 6 weeks 8. Stool is assessed using 16S rRNA/metagenomic sequencing and metabolome analysis at baseline and 6 weeks 9. Liver function is assessed using serum measurements of aspartate aminotransferase, alanine aminotransferase, total bilirubin, conjugated bilirubin, gamma-glutamyl transferase and international normalised ratio at baseline and 6 weeks	—

Measure

Time frame

1. Weight is measured in kg using class III clinical electronic scales at baseline and 1, 2, 3, 4, 5 and 6 weeks post kasai portoenterostomy and converted to age- and sex-adjusted z-scores (WHO, 2009) 2. Length is measured in cm using a recumbent length board at baseline and 6 weeks and converted to age- and sex-adjusted z-scores (WHO, 2009) 3. Head circumference is measured in cm using a disposable paper tape measure at baseline and 6 weeks and converted to age- and sex-adjusted z-scores (WHO, 2009) 4. Mid upper arm circumference is measured in cm using a disposable paper tape measure at baseline and 6 weeks 5. Formula milk intake (ml/kg/day) is measured using the feeding diary over the 6-week period 6. Medium-chain triglyceride intake (g/kg/day) is measured using the feeding diary over the 6-week period 7. Feeding tolerance is measured using the Infant Gastrointestinal Symptom Questionnaire (IGSQ) at baseline and 6 weeks 8. Stool is assessed using 16S rRNA/metagenomic sequencing and metabolome analysis at baseline and 6 weeks 9. Liver function is assessed using serum measurements of aspartate aminotransferase, alanine aminotransferase, total bilirubin, conjugated bilirubin, gamma-glutamyl transferase and international normalised ratio at baseline and 6 weeks

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026