An interventional study of Nutrition Therapy in Chronic Cholestasis, Severe Malnutrition and Pediatric Cholestasis, sponsored by Indonesia University. Recruiting at 1 site in Indonesia. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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:
Participants will:
The study evaluates the effect of nutritional therapy on prealbumin levels and insulin-like growth factor-1 (IGF-1) levels in malnourished children with chronic cholestasis aged 3-59 months (primary outcome) and diet tolerance, nutritional status, and medical condition (secondary outcomes).
Prealbumin and IGF-1 levels are measured as primary outcomes at baseline (day 0) and at day 15. Diet tolerance is assessed using the Bristol Stool Chart, a daily vomiting record throughout the 14-day intervention period, and allergic reactions. The frequency of defecation and consistency of each stool are documented. Allergic reactions are also monitored during the intervention period, including symptoms such as fever, erythematous rash, pruritus, and respiratory symptoms such as shortness of breath. The onset, duration, and severity of these symptoms are recorded.
Vomiting is evaluated as the number of episodes per day over the 14-day intervention period, and the volume of each episode is recorded. Only vomiting attributable to diet intolerance is included in the analysis, while episodes related to other causes, such as coughing or crying, are excluded.
Anthropometric parameters, including weight, height, mid-upper arm circumference, and other relevant measurements, are assessed on day 0, day 8, and day 15 to monitor changes in nutritional status.
Medical conditions during the study period are closely monitored, including underlying diseases, comorbidities, and intercurrent illnesses (e.g., respiratory or gastrointestinal infections). Clinical changes, hospitalizations, medication use, and any complications occurring during the intervention are recorded to evaluate their potential impact on nutritional status and study outcomes.
Nutritional therapy is administered as a liquid diet providing 130% of the recommended daily allowance (RDA), with macronutrient and micronutrient composition adjusted according to the 2019 ESPGHAN and 2021 Tessitore guidelines, over a 14-day intervention period. To ensure accurate nutritional intake, feeding is administered via a nasogastric tube, with gradual advancement of caloric intake until reaching 130% of RDA by day 4. Feeding is performed by parents or caregivers who are trained in proper administration techniques, feeding schedules, and hygiene practices. Monitoring of dietary adherence is conducted by daily food recall, instant messaging, and video call supervision during feeding sessions.
Protocol for nutritional therapy advancement is as follows:
The target energy intake is set at 130% of RDA according to height age, in line with ESPGHAN 2019 and Tessitore 2021 recommendations.
Adjustments to feeding (volume, frequency, or rate) are made based on diet tolerance. If gastrointestinal intolerance or metabolic complications occur, nutritional therapy is modified according to clinical guidelines.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 15 is below the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nutrition therapy
Other: Nutrition Therapy
The nutritional therapy provided consists of a liquid formula with BPOM approval number MD 250976001600096 for subjects under 1 year of age, and BPOM approval number ML 562409102696 for subjects over 1 year of age. Patients are also given micronutrients in the form of vitamins A, D, E, and K, as well as vitamin B1, folic acid, and zinc as needed.
Prealbumin and IGF-1 levels
The difference in prealbumin and IGF-1 levels before and after 14 days of nutritional therapy
Time frame: 15 days
Gastrointestinal tolerance for bowel movement
Frequency of bowel movement per day and description of stool consistency (Bristol stool chart)
Time frame: 14 days
Mid upper arm circumference changes
Mid upper arm circumference changes is assessed using upper arm circumference measurements on the day of baseline and on the fifteenth day (after 14 days of nutritional intervention)
Time frame: 15 days
Height gain
Height gain is a change in height measured in centimetres with 1 decimal. The height gain is defined as the height on day 15 minus the height on day 0. Height on day 0 and day 15 will also be plotted on the WHO Growth Chart height-for-age z-score, and the change of height-for-age z-score will also be measured.
Time frame: 15 days
Other illness duration
Other illness duration refer to the duration of other illness (patient's illness unrelated to their primary illness) in days during the study.
Time frame: 14 days
Gastrointestinal tolerance for vomit
Frequency of vomit per day and volume of vomit
Time frame: 14 days
Prevalence of allergic reaction
Prevalence of subjects whom seems to have allergic reactions (rashes on skin) after receiving nutritional therapy
Time frame: 14 days
Prevalence of vomiting
Prevalence of participants experiencing vomiting after receiving nutrition therapy
Time frame: 14 days
Prevalence of diarrhea
Prevalence of participants experiencing diarrhea after receiving nutritional therapy
Time frame: 14 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Jun 2026, 2 months after the start.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 2 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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