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โ† Trials
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Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy

RecruitingNAAges any - 5 YearsAllUniversitas Indonesia
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In plain words

What the trial is, and whether it could suit you

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 lev

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Nutrition Therapy
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Where

1 site
Faculty of Medicine, University of Indonesia, Jakarta, DKI Jakarta 10430
Jakarta Pusat, Indonesia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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