High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia

March 30, 2026 updated by: Qian Tian, Children's Hospital of Fudan University

Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy

This study is a prospective, single center and observational open clinical study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Biliary atresia (BA) is a significant disease leading to liver failure in infancy, with BA accounting for 50% of infant liver transplantation cases. Many BA children experience complications related to malnutrition, particularly during the first year of life. These complications are primarily characterized by reduced muscle mass and structural protein, impaired bone mineralization, diminished fat reserves, and deficiencies in vitamins and trace elements. Some studies have indicated that oral administration of specialized medium-chain triglycerides (MCT) and branched-chain amino acids FSMP with polysaccharides still result in malnutrition and growth retardation among BA children, necessitating enteral nutrition support treatment through tube feeding. The American Association for the Study of Biliary Atresia conducted a study on the prognosis of 104 children with biliary atresia after Kasai surgery across six clinical centers. They found that the key period for changes in growth rate occurred six months post-surgery, with faster-growing children exhibiting better prognoses compared to those with slower growth rates. Active nutritional therapy can enhance the prognosis of children with biliary atresia, particularly before and after Kasai surgery within the initial six-month period following surgery. Currently, there is no standardized process for using Foods for Special Medical Purpose in China nor any regulations governing the addition and monitoring of trace elements and vitamins. Therefore, this study aims to improve overall outcomes for children with biliary atresia through standardized nutrition assessment procedures as well as education, intervention, and follow-up measures.A total of 300 hospitalized patients were enrolled, all of whom received high MCT formula nutritional support following the Kasai operation, in order to investigate the impact of high MCT formula on the nutritional status and growth of children with biliary atresia after undergoing the Kasai procedure.

Study Type

Observational

Enrollment (Estimated)

300

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tian Qian, M.D. PhD
Phone Number: +8602164931981
Email: drqiantian@fudan.edu.cn

Study Contact Backup

Name: Xiaoyan Gong, Bachelor
Phone Number: +8602164931980
Email: xygongfudan@163.com

Study Locations

China
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200000
    - Recruiting
    - Children's Hospital of Fudan University
    - Contact:
      
      Tian Qian, M.D.
      
      Phone Number: 02164931981
      
      Email: drqiantian@fudan.edu.cn
    - Contact:
      
      Xianyan Gong, Bachelor
      
      Phone Number: 02164931980
      
      Email: xygongfudan@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The Kasai procedure for infants with biliary atresia under the age of 3 months.

Description

Inclusion Criteria:

The Kasai procedure for infants with biliary atresia under the age of 3 months.

Exclusion Criteria:

Complicated with cirrhosis, hepatitis, or other hepatic disorders;
Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort Group / Cohort A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
high MCT formula nutritional support Infants aged 0-3 months who underwent Kasai operation for congenital biliary atresia and were able to receive enteral nutrition through oral or tube feeding were administered a high MCT formula powder + breast milk (with the high MCT formula powder accounting for ≥50%) after the Kasai operation. If breast milk was insufficient, regular formula was used as a substitute. The recommended energy intake was set at 100-130% of DRIs.

Group / Cohort

high MCT formula nutritional support

Infants aged 0-3 months who underwent Kasai operation for congenital biliary atresia and were able to receive enteral nutrition through oral or tube feeding were administered a high MCT formula powder + breast milk (with the high MCT formula powder accounting for ≥50%) after the Kasai operation. If breast milk was insufficient, regular formula was used as a substitute. The recommended energy intake was set at 100-130% of DRIs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Z-scores of body weight Time Frame: 3 months after Kasai portoenterostomy	The patient will be weighed in the recumbent position on an electronic infant scale. Z-scores for weight for age (WAZ) were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	3 months after Kasai portoenterostomy

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

Study Director: Tian Qian, M.D. PhD, Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)