Cholestatic Liver DiseaseNCT05922332
Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease
A study testing Rich medium chain fatty acid milk powder group and Regular milk powder group in people with Cholestatic Liver Disease, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease and To evaluate the safety of feeding milk powder rich in medium chain fatty acids in infants with cholestatic liver disease. Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Cholestatic Liver Disease
- What is being tested?
- Rich medium chain fatty acid milk powder group and Regular milk powder group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 month to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- meets the diagnostic criteria of cholestasis
- Artificial feeding (formula feeders)
- Age ≤6 months
- The course of cholestasis was > 1 month
- Informed consent of the guardian
Who cannot join
- There are major non-cholestatic genetic diseases leading to nutritional intake disorders, such as gastrointestinal malformations
- Cholestasis with ascites and diarrhea
- In patients with oxidative impairment of medium chain fatty acids
Trial locations and contacts
1 site in 1 country.
About this study
To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease and To evaluate the safety of feeding milk powder rich in medium chain fatty acids in infants with cholestatic liver disease.
Read the detailed description
This study will include all types of cholestatic liver disease in infants, randomized controlled study of the efficacy and safety of intervention with rich medium chain fatty acid milk powder,To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease .
- Conditions
- Cholestatic Liver Disease
- Being tested
- Rich medium chain fatty acid milk powder group, Regular milk powder group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rich medium chain fatty acid milk powder groupDietary supplement
In intervention group,there are 32 infants.They will be fed with rich medium chain fatty acid milk powder, formula with MCT content of 39%, total energy of 68kcal/100ml, and feeding frequency at a 3-hour interval
Regular milk powder groupDietary supplement
In control group,there are 32 infants.They will be fed regular milk powder,formula with MCT content of less than 30%, total energy of 67kcal/100ml, and feeding frequency at a 3 hours interval
| Study group | Role | What they receive |
|---|---|---|
| Rich medium chain fatty acid milk powder group | Experimental | This group will be fed milk powder rich in medium-chain fatty acids. The MCT content of formula milk is 39%, and the total energy is 68kcal/100ml. Receives: Dietary Supplement: Rich medium chain fatty acid milk powder group |
| Regular milk powder group | Active comparator | This group will be fed regular milk powder.The MCT content of formula milk is less than 30%, and the total energy is 67kcal/100ml. Receives: Dietary Supplement: Regular milk powder group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-scores of weight for age
The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment.
Measured: "from enrollment to the 4 weekend(28 days)"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Apr 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: The study could not be conducted as a randomized controlled study due to a change in the protocol, and the study needs to be stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholestatic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Children's Hospital of Fudan University Children's Hospital of Fudan University, Study chair, employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922332
- Sponsor's protocol ID
- CHFudanU0530
- Status last verified
- Sep 2025
- First submitted
- 4 Jun 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease
- ClinicalTrials.gov ID
- NCT05922332
- Acronym / sponsor ID
- CHFudanU0530
- Conditions
- Cholestatic Liver Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study could not be conducted as a randomized controlled study due to a change in the protocol, and the study needs to be stopped.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Jun 2023 (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.
To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease and To evaluate the safety of feeding milk powder rich in medium chain fatty acids in infants with cholestatic liver disease.
Detailed description
This study will include all types of cholestatic liver disease in infants, randomized controlled study of the efficacy and safety of intervention with rich medium chain fatty acid milk powder,To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rich medium chain fatty acid milk powder group | Experimental | Dietary Supplement: Rich medium chain fatty acid milk powder groupThis group will be fed milk powder rich in medium-chain fatty acids. The MCT content of formula milk is 39%, and the total energy is 68kcal/100ml. |
| Regular milk powder group | Active comparator | Dietary Supplement: Regular milk powder groupThis group will be fed regular milk powder.The MCT content of formula milk is less than 30%, and the total energy is 67kcal/100ml. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- meets the diagnostic criteria of cholestasis
- Artificial feeding (formula feeders)
- Age ≤6 months
- The course of cholestasis was > 1 month
- Informed consent of the guardian
Key exclusion criteria (3 listed)
- There are major non-cholestatic genetic diseases leading to nutritional intake disorders, such as gastrointestinal malformations
- Cholestasis with ascites and diarrhea
- In patients with oxidative impairment of medium chain fatty acids
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 |
|---|---|---|
| Rich medium chain fatty acid milk powder groupIn intervention group,there are 32 infants.They will be fed with rich medium chain fatty acid milk powder, formula with MCT content of 39%, total energy of 68kcal/100ml, and feeding frequency at a 3-hour interval | Dietary supplement | Rich medium chain fatty acid milk powder group |
| Regular milk powder groupIn control group,there are 32 infants.They will be fed regular milk powder,formula with MCT content of less than 30%, total energy of 67kcal/100ml, and feeding frequency at a 3 hours interval | Dietary supplement | Regular milk powder group |
Primary outcome
Z-scores of weight for age
Time frame: "from enrollment to the 4 weekend(28 days)"
The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Children's Hospital of Fudan University Children's Hospital of Fudan University study chair
employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rich medium chain fatty acid milk powder group and Regular milk powder group in people with Cholestatic Liver Disease, 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Sep 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z-scores of weight for age (time frame: "from enrollment to the 4 weekend(28 days)"). 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 15 Sep 2025.