Nutritional Intervention for Biliary Atresia

Tongji Hospital

Status: Enrolling

Conditions: Nutrition Disorder, Infant; Biliary Atresia

Treatments: Dietary Supplement: normal oral intake of the traditional formula; Dietary Supplement: high MCT formula

Study type: Interventional

Funder types: Other

Identifiers

NCT06764082

Nutr-BA

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 day to 3 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

high MCT group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: high MCT formula

normal treatment group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: normal oral intake of the traditional formula