NCT07569003

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 6, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

April 14, 2026

Last Update Submit

May 1, 2026

Conditions

Chronic CholestasisSevere MalnutritionPediatric Cholestasis

Keywords

Chronic CholestasisSevere malnutritionPediatric cholestasisIGF-1PrealbuminNutrition therapy

Outcome Measures

Primary Outcomes (1)

  • Prealbumin and IGF-1 levels

    The difference in prealbumin and IGF-1 levels before and after 14 days of nutritional therapy

    15 days

Secondary Outcomes (8)

  • Gastrointestinal tolerance for bowel movement

    14 days

  • Mid upper arm circumference changes

    15 days

  • Height gain

    15 days

  • Other illness duration

    14 days

  • Gastrointestinal tolerance for vomit

    14 days

  • +3 more secondary outcomes

Study Arms (1)

Nutrition Therapy Group

EXPERIMENTAL

Nutrition therapy

Other: Nutrition Therapy

Interventions

Nutrition TherapyOTHER

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.

Nutrition Therapy Group

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, University of Indonesia, Jakarta, DKI Jakarta 10430

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Tri Faranita, dr, Sp.A

    Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tri Faranita, dr, Sp.A

CONTACT

+628126016641tri.faranita@ui.ac.id

Klara Yuliarti, Dr. dr, Sp.A(K)

CONTACT

+628129300755klarayuliarti@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre and post design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatrician, Fellow in Pediatric Nutrition and Metabolic Diseases

Study Record Dates

First Submitted

April 14, 2026

First Posted

May 6, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

ID(1)