Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease

Conditions
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Cholestatic Liver Disease

Intervention / Treatment
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* Dietary Supplement: Rich medium chain fatty acid milk powder group
* Dietary Supplement: Regular milk powder group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rich medium chain fatty acid milk powder group<br>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. | Dietary Supplement: Rich medium chain fatty acid milk powder group<br>* 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<br>|
| Active Comparator: Regular milk powder group<br>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. | Dietary Supplement: Regular milk powder group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Z-scores of weight for age | The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment. | from enrollment to the 4 weekend(28 days) |