Nutrition Disorder, InfantNCT06764082
Nutritional Intervention for Biliary Atresia
A study testing high MCT formula and normal oral intake of the traditional formula in people with Nutrition Disorder, Infant and Biliary Atresia, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Nutrition Disorder, Infant, Biliary Atresia
- What is being tested?
- high MCT formula and normal oral intake of the traditional formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Jiexiong Feng, MD., 00862783665309, fengjiexiong@126.com
About this study
Official title: Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial
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.
- Conditions
- Nutrition Disorder, Infant, Biliary Atresia
- Being tested
- high MCT formula, normal oral intake of the traditional formula
- Medical subject headings
- Infant Nutrition Disorders, Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high MCT formulaDietary supplement
Energy Intake: The tube-feeding formula was a special medical-purpose formula food with high MCT and deep hydrolyzed milk protein (Alfare, Nestlé, Switzerland), which contained hydrolyzed whey protein, maltodextrin, vegetable oil, and MCT, etc. 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).
Feeding Procedure: 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. After the operation, starting from when oral nutrition was feasible, the amount gradually increased from the initial amount until the expected amount was reached, and this continued until 6 months after the operation. The difference between the estimated feeding amount and the actual feeding amount could be selectively supplemented with enteral nutrition (nasogastric tube).
normal oral intake of the traditional formulaDietary supplement
For the children in the control group, there were no special restrictions before the operation. After they were able to have a normal diet postoperatively, they were encouraged to have a normal oral intake of the traditional formula. The recommended energy input for the formula was 130 - 150% of the reference intake (DRI) based on age and gender as per the World Health Organization (WHO). The final dosage and schedule were determined by the children and their parents or caregivers. The feeding route and the schedule for complementary feeding were the same as those in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| high MCT group | Experimental | 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. Receives: Dietary Supplement: high MCT formula |
| normal treatment group | Active comparator | 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. Receives: Dietary Supplement: normal oral intake of the traditional formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
age by weight Z score
scores
Measured: 6 months
Secondary outcomes (1)
age by height Z score
scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Feb 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Disorder, InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Jiexiong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764082
- Sponsor's protocol ID
- Nutr-BA
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial
- ClinicalTrials.gov ID
- NCT06764082
- Acronym / sponsor ID
- Nutr-BA
- Conditions
- Nutrition Disorder, Infant, Biliary Atresia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high MCT group | Experimental | Dietary Supplement: high MCT formulaAt 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. |
| normal treatment group | Active comparator | Dietary Supplement: normal oral intake of the traditional formulaThe 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. |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high MCT formulaEnergy Intake: The tube-feeding formula was a special medical-purpose formula food with high MCT and deep hydrolyzed milk protein (Alfare, Nestlé, Switzerland), which contained hydrolyzed whey protein, maltodextrin, vegetable oil, and MCT, etc. 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). Feeding Procedure: 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. After the operation, starting from when oral nutrition was feasible, the amount gradually increased from the initial amount until the expected amount was reached, and this continued until 6 months after the operation. The difference between the estimated feeding amount and the actual feeding amount could be selectively supplemented with enteral nutrition (nasogastric tube). | Dietary supplement | high MCT group |
| normal oral intake of the traditional formulaFor the children in the control group, there were no special restrictions before the operation. After they were able to have a normal diet postoperatively, they were encouraged to have a normal oral intake of the traditional formula. The recommended energy input for the formula was 130 - 150% of the reference intake (DRI) based on age and gender as per the World Health Organization (WHO). The final dosage and schedule were determined by the children and their parents or caregivers. The feeding route and the schedule for complementary feeding were the same as those in the experimental group. | Dietary supplement | normal treatment group |
Primary outcome
age by weight Z score
Time frame: 6 months
scores
1 secondary outcome
age by height Z score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high MCT formula and normal oral intake of the traditional formula in people with Nutrition Disorder, Infant and Biliary Atresia, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age by weight Z score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.