Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutri… (NCT07569003) | Clinical Trial Compass
RecruitingNot Applicable
Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy
Indonesia15 participantsStarted 2026-04-06
Plain-language summary
The goal of this clinical trial is to learn if a high-energy liquid diet improves the nutritional status of children with chronic cholestasis (a liver condition that blocks bile flow). Researchers want to see if this diet helps children who are malnourished.
The main questions the study aims to answer are:
* Does the liquid diet raise the level of prealbumin (a marker of nutrition) in the blood?
* Does the liquid diet raise the level of Insulin-like Growth Factor-1 (IGF-1) (a hormone that helps growth) in the blood?
Participants will:
* Consume a high-energy liquid diet for 14 days.
* Give blood samples at the start and at the end of the 2-week study.
* Keep a daily record of what they eat and drink in a food diary. Researchers will compare the blood test results from the start and the end of the study to see if the liquid diet works to improve the children's prealbumin and IGF-1 levels. This study is important to help children with liver problems grow better and stay healthy.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.