NCT06764082

Nutritional Intervention for Biliary Atresia

Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 3 Months
• Healthy volunteers: Not accepted

Summary

Infants with biliary atresia (Biliary atresia, BA) have an increased risk of malnutrition due to insufficient dietary intake to maintain normal growth, impaired intestinal absorption, increased metabolic rate, and damage to some liver macronutrient metabolic pathways. The medium-chain triglyceride formula (MCT) in enteral nutrition has advantages: (1) It has a fast metabolism in the liver and possesses the advantage of being an innate energy source; (2) It can share metabolic pathways with some other fatty acids (DHA, EPA), and can promote the synthesis of phospholipids, etc. Therefore, EN containing the MCT formula is regarded as an important approach to alleviate growth retardation in BA children and improve the nutritional status of patients. This study aims to observe the effect of intensified enteral feeding with a high MCT formula during the perioperative period compared to traditional oral feeding on the prognosis of children with biliary atresia. The method adopted is a prospective, two-arm, open-label, multicenter, and interventional real-world study.

Conditions

• Nutrition Disorder, Infant
• Biliary Atresia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	high MCT formula	Energy Intake: The tube-feeding formula was a special medical-purpose formula food with high MCT and deep hydrolyzed milk protein (Alfare, Nestlé, Switzerland), which contained hydrolyzed whey protein, maltodextrin, vegetable oil, and MCT, etc. At a high-calorie concentration, each 1000 mL could provide 800 kcal, 15.8 g MCT, and 21.5 g protein (osmotic pressure 227 mOsm/kg). Feeding Procedure: On the basis of 130 - 150% DRI, a high-calorie formula feeding amount of 160 ml/kg/d could provide 2.7 g/kg/d MCT. After the operation, starting from when oral nutrition was feasible, the amount gradually increased from the initial amount until the expected amount was reached, and this continued until 6 months after the operation. The difference between the estimated feeding amount and the actual feeding amount could be selectively supplemented with enteral nutrition (nasogastric tube).
DIETARY_SUPPLEMENT	normal oral intake of the traditional formula	For the children in the control group, there were no special restrictions before the operation. After they were able to have a normal diet postoperatively, they were encouraged to have a normal oral intake of the traditional formula. The recommended energy input for the formula was 130 - 150% of the reference intake (DRI) based on age and gender as per the World Health Organization (WHO). The final dosage and schedule were determined by the children and their parents or caregivers. The feeding route and the schedule for complementary feeding were the same as those in the experimental group.

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2025-01-08
• Last updated: 2025-12-22

Locations

1 site across 1 country: China