NCT06764082 Nutritional Intervention for Biliary Atresia
| NCT ID | NCT06764082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Nutrition Disorder, Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-02-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT06764082 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 3 Months, studying Nutrition Disorder, Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06764082 currently recruiting?
Yes, NCT06764082 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tongji Hospital to inquire about joining.
Where is the NCT06764082 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06764082 clinical trial?
NCT06764082 is sponsored by Tongji Hospital. The trial plans to enroll 120 participants.