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

Fudan University

Status: Withdrawn

Conditions: Cholestatic Liver Disease

Treatments: Dietary Supplement: Rich medium chain fatty acid milk powder group; Dietary Supplement: Regular milk powder group

Study type: Interventional

Funder types: Other

Identifiers

NCT05922332

CHFudanU0530

Details and patient eligibility

About

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.

Full 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 .

Sex: All

Ages: 1 to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Rich medium chain fatty acid milk powder group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Rich medium chain fatty acid milk powder group

Regular milk powder group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Regular milk powder group