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

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: Infant; Biliary Atresia; Nutrition Support; Medium-chain Triglyceride
• Intervention / Treatment: Combination product: high MCT formula; Dietary supplement: MCT powder

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

• 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

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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	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

Outcome Measure	Measure Description	Time Frame
Z-scores of body length	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	1 month after Kasai portoenterostomy
Z-scores of body length	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	3 months after Kasai portoenterostomy
Z-scores of body length	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	6 months after Kasai portoenterostomy
Z-scores of body length	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	1 year after Kasai portoenterostomy
Z-scores of body weight	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	1 month after Kasai portoenterostomy
Z-scores of body weight	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	6 months after Kasai portoenterostomy
Z-scores of body weight	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	1 year after Kasai portoenterostomy
Z-scores of head circumference	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	1 month after Kasai portoenterostomy
Z-scores of head circumference	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	3 months after Kasai portoenterostomy
Z-scores of head circumference	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	6 months after Kasai portoenterostomy
Z-scores of head circumference	Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.	1 year after Kasai portoenterostomy
level of vitamin A	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
level of vitamin A	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
level of vitamin A	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
level of vitamin A	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
level of 25（OH) D	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
level of 25（OH) D	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
level of 25（OH） D	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
level of 25（OH） D	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
level of vitamin E	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
level of vitamin E	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
level of vitamin E	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
level of vitamin E	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
level of vitamin K	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
level of vitamin K	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
level of vitamin K	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
level of vitamin K	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
Aspartate aminotransferase	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
Aspartate aminotransferase	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
Aspartate aminotransferase	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
Aspartate aminotransferase	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
Alanine aminotransferase	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
Alanine aminotransferase	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
Alanine aminotransferase	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
Alanine aminotransferase	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
Total Bilirubin	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
Total Bilirubin	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
Total Bilirubin	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
Total Bilirubin	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
Direct Bilirubin	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
Direct Bilirubin	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
Direct Bilirubin	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
Direct Bilirubin	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
Gamma-glutamyl transferase	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
Gamma-glutamyl transferase	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
Gamma-glutamyl transferase	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
Gamma-glutamyl transferase	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
Total bile acid	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
Total bile acid	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
Total bile acid	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
Total bile acid	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
White blood cell	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
White blood cell	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
White blood cell	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
White blood cell	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
lymphocyte	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
lymphocyte	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
lymphocyte	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
lymphocyte	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
Neutrophil count	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
Neutrophil count	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
Neutrophil count	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
Neutrophil count	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
International Normalized Ratio	Blood biochemical data are from clinical database.	1 month after Kasai portoenterostomy
International Normalized Ratio	Blood biochemical data are from clinical database.	3 months after Kasai portoenterostomy
International Normalized Ratio	Blood biochemical data are from clinical database.	6 months after Kasai portoenterostomy
International Normalized Ratio	Blood biochemical data are from clinical database.	1 year after Kasai portoenterostomy
Incidence of postoperative cholangitis	Data from clinical database	1 year after Kasai portoenterostomy
Liver transplantation	Data from clinical database	1 year after Kasai portoenterostomy
MMP-7	Data from clinical database	1 months after Kasai portoenterostomy
MMP-7	Data from clinical database	3 months after Kasai portoenterostomy
MMP-7	Data from clinical database	6 months after Kasai portoenterostomy
MMP-7	Data from clinical database	1 year after Kasai portoenterostomy
Intestinal flora	Data from clinical database	1 months after Kasai portoenterostomy
Intestinal flora	Data from clinical database	3 months after Kasai portoenterostomy
Intestinal flora	Data from clinical database	6 months after Kasai portoenterostomy
Intestinal flora	Data from clinical database	1 year after Kasai portoenterostomy
bile acid spectrum	Data from clinical database	1 months after Kasai portoenterostomy
bile acid spectrum	Data from clinical database	3 months after Kasai portoenterostomy
bile acid spectrum	Data from clinical database	6 months after Kasai portoenterostomy
bile acid spectrum	Data from clinical database	1 year after Kasai portoenterostomy

Collaborators and Investigators

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

Study record dates

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): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Biliary Atresia; Kasai portoenterostomy; Nutrition Support; medium-chain triglyceride
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Congenital Abnormalities; Bile Duct Diseases; Digestive System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Biliary Atresia
• Other Study ID Numbers: （2020）287

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No