High-energy liquid diet for young children with chronic cholestasis and severe malnutrition
Preliminary Study: Effect of Nutrition Therapy on Prealbumin and IGF-1 Level in Severe Malnutrition Under Five Years Old With Chronic Cholestasis
NA · Indonesia University · NCT07569003
This project will see if a 14-day high-energy liquid diet can raise prealbumin and IGF-1 blood levels in children under 5 with chronic cholestasis and severe malnutrition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 5 Years |
| Sex | All |
| Sponsor | Indonesia University (other) |
| Locations | 1 site (Jakarta Pusat, DKI Jakarta) |
| Trial ID | NCT07569003 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 3 to 59 months with diagnosed chronic cholestasis and severe malnutrition whose guardians consent and who can use a nasogastric tube if indicated.
Not a fit: Children with heart failure, chronic kidney disease, HIV, recent severe acute infections, post-transplant status, or those who are exclusively breastfed are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the diet could improve short-term nutrition markers and help support growth in malnourished children with chronic cholestasis.
How similar studies have performed: Prior nutritional interventions in cholestatic pediatric populations have shown improvements in weight and some biochemical markers, but short-term effects on prealbumin and IGF-1 from a 14-day high-energy liquid diet are not well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jakarta Pusat, DKI Jakarta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Cholestasis, Severe Malnutrition, Pediatric Cholestasis, Severe malnutrition, Pediatric cholestasis, IGF-1, Prealbumin, Nutrition therapy