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

Not Applicable
Withdrawn
Conditions
Cholestatic Liver Disease
Registration Number
NCT05922332
Lead Sponsor
Children's Hospital of Fudan University
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 .

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
64
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

zhaoyang Gou

🇨🇳

Shanghai, China

zhaoyang Gou
🇨🇳Shanghai, China

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