High-energy liquid diet for young children with chronic cholestasis and severe malnutrition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls malnourished children aged 3 to 59 months with chronic cholestasis to receive a prescribed high-energy liquid diet for 14 days. Blood samples for prealbumin and IGF-1 are taken at baseline and on day 15 to measure biochemical response. Daily food diaries, stool and vomiting records, and monitoring for allergic reactions are collected throughout the intervention, while anthropometric measurements are recorded on days 0, 8, and 15. The protocol excludes children with major comorbidities, recent severe infections, post-transplant status, or exclusive breastfeeding.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children under 5 years old
* Diagnosed with chronic cholestasis and severe malnutrition
* Parental/guardian informed consent
* Willingness to use a nasogastric tube (NGT) if indicated
* Covered by national health insurance or other insurance

Exclusion Criteria:

* Comorbidities (heart failure, chronic kidney disease, HIV)
* Severe acute infections (acute gastroenteritis, dengue fever, pneumonia)
* Post-liver transplant
* Post-Kasai portoenterostomy (jaundice-free)
* Currently exclusively breastfeeding
* Use of steroids or NSAIDs within two weeks prior to the study.
* Receiving a transfusion of whole blood, fresh frozen plasma, or platelets within one week prior to the study

Where it's running

• Faculty of Medicine, University of Indonesia, Jakarta, DKI Jakarta 10430
  Jakarta Pusat, DKI Jakarta, Indonesia Recruiting

Study contacts

• Principal investigator: Tri Faranita, dr, Sp.A — Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
• Study coordinator: Tri Faranita, dr, Sp.A
• Email: tri.faranita@ui.ac.id
• Phone: +628126016641

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.