NCT05072626

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Biliary Atresia
• Infant
• Nutrition Support
• Medium-chain Triglyceride

Timeline

• Start date: 2021-10-11
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2021-10-11
• Last updated: 2026-04-03

Locations

1 site across 1 country: China