Cholestatic Liver Disease
Conditions
Brief 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.
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 .
Interventions
DIETARY_SUPPLEMENTRich medium chain fatty acid milk powder group
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
DIETARY_SUPPLEMENTRegular milk powder group
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
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Z-scores of weight for age | from enrollment to the 4 weekend(28 days) | The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment. |
Countries
China
Outcome results
None listed