High-MCT nutritional support for infants with biliary atresia
Official title: Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial
Run by Tongji Hospital · NCT06764082 · Data updated 2026-11-12
We will test whether giving a high medium-chain triglyceride (MCT) formula before and after Kasai surgery helps infants with biliary atresia grow better and recover faster than standard feeding.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 3 Months |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06764082 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants younger than three months with a clinical diagnosis of biliary atresia who are scheduled for Kasai surgery and whose parents provide informed consent are ideal candidates.
✕Probably not a fit
Infants with very low birth weight, life-threatening organ system diseases, major digestive malformations, recent clinical trial participation, or other conditions the investigator deems unsuitable are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective interventional comparison will give intensified enteral feeding with a high MCT formula during the perioperative period to infants with biliary atresia and compare outcomes to those receiving traditional oral feeding. Eligible infants are under three months old and scheduled to undergo Kasai portoenterostomy, with parental consent required for participation. Study staff will monitor growth measurements, biochemical nutritional markers, and clinical recovery after surgery to determine effects on nutritional status and short-term prognosis. Infants with very low birth weight, severe comorbidities, major digestive tract malformations, recent participation in other trials, or other contraindications will be excluded.
Why it matters
Potential benefit: If successful, intensified MCT enteral feeding could reduce malnutrition, support better growth, and improve short-term recovery after Kasai surgery for infants with biliary atresia.
How similar studies have gone: Some prior studies in cholestatic pediatric populations have shown benefits from MCT-enriched feeding, but intensified perioperative MCT use specifically for biliary atresia is relatively novel and not yet widely established.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Tongji Hospital
Wuhan, Hubei, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.