Nutritional Intervention for Biliary Atresia

NCT ID: NCT06764082

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

high MCT group

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). 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.

Group Type: EXPERIMENTAL

high MCT formula

Intervention Type: DIETARY_SUPPLEMENT

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).

normal treatment group

The recommended energy input was 130-150% of the reference intake (DRI) based on age and gender as per WHO. The final dosage and schedule were determined by the children and their parents or caregivers.

Group Type: ACTIVE_COMPARATOR

normal oral intake of the traditional formula

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Infants under 3 months old;
• Children clinically diagnosed with biliary atresia and in need of Kasai surgery;
• The patient themselves, legal representative or guardian have signed the informed consent form and are willing to actively cooperate with treatment and follow-up.

Exclusion Criteria

• Low birth weight infants or very low birth weight infants;
• Complicated with life-threatening diseases of various organ systems;
• Complicated with other severe digestive tract malformations or other diseases that may interfere with the treatment of the patient or the patient's compliance;
• Patients who have participated in other clinical trials within the last month;
• Any other conditions that the researcher deems unsuitable for participation in this trial.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Feng Jiexiong

pediatric surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jiexiong Feng, MD.

Role: primary

Other Identifiers

Nutr-BA

Identifier Type: -

Identifier Source: org_study_id