Effectiveness of oral methylprednisolone as an additional treatment for infants with cholestasis in Dr Soetomo General Academic Hospital, Surabaya, Indonesia

Effectiveness of oral methylprednisolone as adjuvant therapy on clinical improvement, biochemical markers, and inflammation in infants with cholestasis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45080388

Enrollment

Registered

2022-10-29

Start date

2022-10-13

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestasis Digestive System

Interventions

Subjects are randomised into two groups, namely: 1. Methylprednisolone (+)/intervention group: receive a combination of oral methylprednisolone (generic) and standard therapy for 14 days with dose 2 m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Suffered from cholestasis 2. Aged 14 days to 3 months old

Exclusion criteria

Exclusion criteria: 1. Suffering from congenital abnormalities 2. Suffering from genetic disorders 3. Suffering from severe infection/sepsis 4. Hemodynamic condition is unstable 5. Parents refuse to participate in research

Design outcomes

Primary

Measure	Time frame
1. Stool colour measured using stool colour card at baseline and 14 days 2. Level of AST, ALT and bilirubin measured using ELISA at baseline and 14 days 3. Level of marker inflammation (IFN-?, IL1ß, IL2, IL4, IL6, IL10, TGF-ß, ANCA) measured using ELISA at baseline and 14 days	—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026