Biliary AtresiaNCT05072626
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
An observational study of Biliary Atresia and Infant, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study is a prospective, single center and observational open clinical study. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Biliary Atresia, Infant, Nutrition Support
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2021to 31 Dec 2028
- Phase
- Observational
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: The Kasai procedure for infants with biliary atresia under the age of 3 months.
Who may be able to join
- The Kasai procedure for infants with biliary atresia under the age of 3 months.
Who cannot join
- Complicated with cirrhosis, hepatitis, or other hepatic disorders;
- Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)
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
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Tian Qian, M.D., 02164931981, drqiantian@fudan.edu.cn
Xianyan Gong, Bachelor, 02164931980, xygongfudan@163.com
About this study
Official title: Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
This study is a prospective, single center and observational open clinical study.
Read the detailed description
Biliary atresia (BA) is a significant disease leading to liver failure in infancy, with BA accounting for 50% of infant liver transplantation cases. Many BA children experience complications related to malnutrition, particularly during the first year of life. These complications are primarily characterized by reduced muscle mass and structural protein, impaired bone mineralization, diminished fat reserves, and deficiencies in vitamins and trace elements. Some studies have indicated that oral administration of specialized medium-chain triglycerides (MCT) and branched-chain amino acids FSMP with polysaccharides still result in malnutrition and growth retardation among BA children, necessitating enteral nutrition support treatment through tube feeding. The American Association for the Study of Biliary Atresia conducted a study on the prognosis of 104 children with biliary atresia after Kasai surgery across six clinical centers. They found that the key period for changes in growth rate occurred six months post-surgery, with faster-growing children exhibiting better prognoses compared to those with slower growth rates. Active nutritional therapy can enhance the prognosis of children with biliary atresia, particularly before and after Kasai surgery within the initial six-month period following surgery. Currently, there is no standardized process for using Foods for Special Medical Purpose in China nor any regulations governing the addition and monitoring of trace elements and vitamins. Therefore, this study aims to improve overall outcomes for children with biliary atresia through standardized nutrition assessment procedures as well as education, intervention, and follow-up measures.A total of 300 hospitalized patients were enrolled, all of whom received high MCT formula nutritional support following the Kasai operation, in order to investigate the impact of high MCT formula on the nutritional status and growth of children with biliary atresia after undergoing the Kasai procedure.
- Conditions
- Biliary Atresia, Infant, Nutrition Support, Medium-chain Triglyceride
- Keywords
- Biliary Atresia, Kasai portoenterostomy, Nutrition Support, medium-chain triglyceride
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| high MCT formula nutritional support | Infants aged 0-3 months who underwent Kasai operation for congenital biliary atresia and were able to receive enteral nutrition through oral or tube feeding were administered a high MCT formula powder + breast milk (with the high MCT formula powder accounting for ≥50%) after the Kasai operation. If breast milk was insufficient, regular formula was used as a substitute. The recommended energy intake was set at 100-130% of DRIs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-scores of body weight
The patient will be weighed in the recumbent position on an electronic infant scale. Z-scores for weight for age (WAZ) were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 3 months after Kasai portoenterostomy
Secondary outcomes (81)
Z-scores of body length
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 1 month after Kasai portoenterostomy
Z-scores of body length
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 3 months after Kasai portoenterostomy
Z-scores of body length
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 6 months after Kasai portoenterostomy
Z-scores of body length
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 1 year after Kasai portoenterostomy
Z-scores of body weight
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 1 month after Kasai portoenterostomy
Z-scores of body weight
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 6 months after Kasai portoenterostomy
Z-scores of body weight
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 1 year after Kasai portoenterostomy
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 1 month after Kasai portoenterostomy
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 3 months after Kasai portoenterostomy
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 6 months after Kasai portoenterostomy
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 1 year after Kasai portoenterostomy
level of vitamin A
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
level of vitamin A
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
level of vitamin A
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
level of vitamin A
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
level of 25（OH) D
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
level of 25（OH) D
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
level of 25（OH） D
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
level of 25（OH） D
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
level of vitamin E
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
level of vitamin E
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
level of vitamin E
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
level of vitamin E
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
level of vitamin K
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
level of vitamin K
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
level of vitamin K
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
level of vitamin K
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
Aspartate aminotransferase
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
Aspartate aminotransferase
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
Aspartate aminotransferase
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
Aspartate aminotransferase
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
Alanine aminotransferase
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
Alanine aminotransferase
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
Alanine aminotransferase
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
Alanine aminotransferase
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
Total Bilirubin
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
Total Bilirubin
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
Total Bilirubin
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
Total Bilirubin
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
Direct Bilirubin
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
Direct Bilirubin
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
Direct Bilirubin
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
Direct Bilirubin
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
Gamma-glutamyl transferase
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
Gamma-glutamyl transferase
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
Gamma-glutamyl transferase
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
Gamma-glutamyl transferase
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
Total bile acid
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
Total bile acid
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
Total bile acid
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
Total bile acid
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
White blood cell
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
White blood cell
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
White blood cell
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
White blood cell
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
lymphocyte
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
lymphocyte
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
lymphocyte
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
lymphocyte
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
Neutrophil count
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
Neutrophil count
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
Neutrophil count
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
Neutrophil count
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
International Normalized Ratio
Blood biochemical data are from clinical database.
Measured: 1 month after Kasai portoenterostomy
International Normalized Ratio
Blood biochemical data are from clinical database.
Measured: 3 months after Kasai portoenterostomy
International Normalized Ratio
Blood biochemical data are from clinical database.
Measured: 6 months after Kasai portoenterostomy
International Normalized Ratio
Blood biochemical data are from clinical database.
Measured: 1 year after Kasai portoenterostomy
Incidence of postoperative cholangitis
Data from clinical database
Measured: 1 year after Kasai portoenterostomy
Liver transplantation
Data from clinical database
Measured: 1 year after Kasai portoenterostomy
MMP-7
Data from clinical database
Measured: 1 months after Kasai portoenterostomy
MMP-7
Data from clinical database
Measured: 3 months after Kasai portoenterostomy
MMP-7
Data from clinical database
Measured: 6 months after Kasai portoenterostomy
MMP-7
Data from clinical database
Measured: 1 year after Kasai portoenterostomy
Intestinal flora
Data from clinical database
Measured: 1 months after Kasai portoenterostomy
Intestinal flora
Data from clinical database
Measured: 3 months after Kasai portoenterostomy
Intestinal flora
Data from clinical database
Measured: 6 months after Kasai portoenterostomy
Intestinal flora
Data from clinical database
Measured: 1 year after Kasai portoenterostomy
bile acid spectrum
Data from clinical database
Measured: 1 months after Kasai portoenterostomy
bile acid spectrum
Data from clinical database
Measured: 3 months after Kasai portoenterostomy
bile acid spectrum
Data from clinical database
Measured: 6 months after Kasai portoenterostomy
bile acid spectrum
Data from clinical database
Measured: 1 year after Kasai portoenterostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start11 Oct 2021
- Primary completion31 Dec 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 Biliary AtresiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Tian, Children's Hospital of Fudan University
- Investigators
- Tian Qian, M.D. PhD, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072626
- Sponsor's protocol ID
- （2020）287
- Status last verified
- Mar 2026
- First submitted
- 13 Sep 2021
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
- ClinicalTrials.gov ID
- NCT05072626
- Acronym / sponsor ID
- （2020）287
- Conditions
- Biliary Atresia, Infant, Nutrition Support, Medium-chain Triglyceride
- Keywords
- Biliary Atresia, Kasai portoenterostomy, Nutrition Support, medium-chain triglyceride
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Oct 2021 (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.
This study is a prospective, single center and observational open clinical study.
Detailed description
Biliary atresia (BA) is a significant disease leading to liver failure in infancy, with BA accounting for 50% of infant liver transplantation cases. Many BA children experience complications related to malnutrition, particularly during the first year of life. These complications are primarily characterized by reduced muscle mass and structural protein, impaired bone mineralization, diminished fat reserves, and deficiencies in vitamins and trace elements. Some studies have indicated that oral administration of specialized medium-chain triglycerides (MCT) and branched-chain amino acids FSMP with polysaccharides still result in malnutrition and growth retardation among BA children, necessitating enteral nutrition support treatment through tube feeding. The American Association for the Study of Biliary Atresia conducted a study on the prognosis of 104 children with biliary atresia after Kasai surgery across six clinical centers. They found that the key period for changes in growth rate occurred six months post-surgery, with faster-growing children exhibiting better prognoses compared to those with slower growth rates. Active nutritional therapy can enhance the prognosis of children with biliary atresia, particularly before and after Kasai surgery within the initial six-month period following surgery. Currently, there is no standardized process for using Foods for Special Medical Purpose in China nor any regulations governing the addition and monitoring of trace elements and vitamins. Therefore, this study aims to improve overall outcomes for children with biliary atresia through standardized nutrition assessment procedures as well as education, intervention, and follow-up measures.A total of 300 hospitalized patients were enrolled, all of whom received high MCT formula nutritional support following the Kasai operation, in order to investigate the impact of high MCT formula on the nutritional status and growth of children with biliary atresia after undergoing the Kasai procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high MCT formula nutritional support | – | –Infants aged 0-3 months who underwent Kasai operation for congenital biliary atresia and were able to receive enteral nutrition through oral or tube feeding were administered a high MCT formula powder + breast milk (with the high MCT formula powder accounting for ≥50%) after the Kasai operation. If breast milk was insufficient, regular formula was used as a substitute. The recommended energy intake was set at 100-130% of DRIs. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The Kasai procedure for infants with biliary atresia under the age of 3 months.
Key inclusion criteria (1 listed)
- The Kasai procedure for infants with biliary atresia under the age of 3 months.
Key exclusion criteria (2 listed)
- Complicated with cirrhosis, hepatitis, or other hepatic disorders;
- Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Z-scores of body weight
Time frame: 3 months after Kasai portoenterostomy
The patient will be weighed in the recumbent position on an electronic infant scale. Z-scores for weight for age (WAZ) were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
81 secondary outcomes
Z-scores of body length
Time frame: 1 month after Kasai portoenterostomy
Z-scores of body length
Time frame: 3 months after Kasai portoenterostomy
Z-scores of body length
Time frame: 6 months after Kasai portoenterostomy
Z-scores of body length
Time frame: 1 year after Kasai portoenterostomy
Z-scores of body weight
Time frame: 1 month after Kasai portoenterostomy
Z-scores of body weight
Time frame: 6 months after Kasai portoenterostomy
Z-scores of body weight
Time frame: 1 year after Kasai portoenterostomy
Z-scores of head circumference
Time frame: 1 month after Kasai portoenterostomy
Z-scores of head circumference
Time frame: 3 months after Kasai portoenterostomy
Z-scores of head circumference
Time frame: 6 months after Kasai portoenterostomy
Z-scores of head circumference
Time frame: 1 year after Kasai portoenterostomy
level of vitamin A
Time frame: 1 month after Kasai portoenterostomy
level of vitamin A
Time frame: 3 months after Kasai portoenterostomy
level of vitamin A
Time frame: 6 months after Kasai portoenterostomy
level of vitamin A
Time frame: 1 year after Kasai portoenterostomy
level of 25（OH) D
Time frame: 1 month after Kasai portoenterostomy
level of 25（OH) D
Time frame: 3 months after Kasai portoenterostomy
level of 25（OH） D
Time frame: 6 months after Kasai portoenterostomy
level of 25（OH） D
Time frame: 1 year after Kasai portoenterostomy
level of vitamin E
Time frame: 1 month after Kasai portoenterostomy
level of vitamin E
Time frame: 3 months after Kasai portoenterostomy
level of vitamin E
Time frame: 6 months after Kasai portoenterostomy
level of vitamin E
Time frame: 1 year after Kasai portoenterostomy
level of vitamin K
Time frame: 1 month after Kasai portoenterostomy
level of vitamin K
Time frame: 3 months after Kasai portoenterostomy
level of vitamin K
Time frame: 6 months after Kasai portoenterostomy
level of vitamin K
Time frame: 1 year after Kasai portoenterostomy
Aspartate aminotransferase
Time frame: 1 month after Kasai portoenterostomy
Aspartate aminotransferase
Time frame: 3 months after Kasai portoenterostomy
Aspartate aminotransferase
Time frame: 6 months after Kasai portoenterostomy
Aspartate aminotransferase
Time frame: 1 year after Kasai portoenterostomy
Alanine aminotransferase
Time frame: 1 month after Kasai portoenterostomy
Alanine aminotransferase
Time frame: 3 months after Kasai portoenterostomy
Alanine aminotransferase
Time frame: 6 months after Kasai portoenterostomy
Alanine aminotransferase
Time frame: 1 year after Kasai portoenterostomy
Total Bilirubin
Time frame: 1 month after Kasai portoenterostomy
Total Bilirubin
Time frame: 3 months after Kasai portoenterostomy
Total Bilirubin
Time frame: 6 months after Kasai portoenterostomy
Total Bilirubin
Time frame: 1 year after Kasai portoenterostomy
Direct Bilirubin
Time frame: 1 month after Kasai portoenterostomy
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 3 Apr 2026.
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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.
Tian Qian, M.D. PhD study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia and Infant, run by Children's Hospital of Fudan University 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 1 inclusion and 2 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 3 Apr 2026. 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?
Contact Tian Qian, M.D. PhD (+8602164931981, drqiantian@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z-scores of body weight (time frame: 3 months after Kasai portoenterostomy). 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 3 Apr 2026.