Nutritional Intervention for Biliary Atresia

Not Applicable

Not yet recruiting

• Conditions: Nutrition Disorder, Infant; Biliary Atresia

• Registration Number: NCT06764082
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Study Start: 2025-02-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1. Infants under 3 months old; 2. Children clinically diagnosed with biliary atresia and in need of Kasai surgery; 3. 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

• 1. Low birth weight infants or very low birth weight infants; 2. Complicated with life-threatening diseases of various organ systems; 3. Complicated with other severe digestive tract malformations or other diseases that may interfere with the treatment of the patient or the patient's compliance; 4. Patients who have participated in other clinical trials within the last month; 5. Any other conditions that the researcher deems unsuitable for participation in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
age by weight Z score	6 months	scores

Secondary Outcome Measures

Name	Time	Method
age by height Z score	6 months	scores