High-MCT nutritional support for infants with biliary atresia
Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial
NA · Tongji Hospital · NCT06764082
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Day to 3 Months |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06764082 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nutrition Disorder, Infant, Biliary Atresia