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

Cholestatic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05922332
• Other study ID #: CHFudanU0530
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: zhaoyang Gou zhaoyang Gou
• Phone: 18702113705
• Email: zy18702113705[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Cholestasis
• Cholestatic Liver Disease
• Liver Diseases

Intervention

Dietary Supplement:
• Rich 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
• Regular 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

Locations

Country	Name	City	State
China	zhaoyang Gou	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)"