Effectiveness of oral methylprednisolone as an additional treatment for infants with cholestasis in Dr Soetomo General Academic Hospital, Surabaya, Indonesia
| ISRCTN | ISRCTN45080388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45080388 |
| Secondary identifying numbers | 0468/KEPK/VIII/2022 |
- Submission date
- 22/10/2022
- Registration date
- 29/10/2022
- Last edited
- 09/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Cholestasis is an obstruction of bile flow which causes disruption of the secretion of various substances from the liver into the duodenum (small intestine), so that these materials are retained in the liver and cause damage. The diagnosis of cholestasis is based on clinical conditions and laboratory tests. Clinically, the baby looks yellow (jaundice) with a serum direct bilirubin level over 1.5 mg/dl and/or over 15% of the total bilirubin level. Oral corticosteroids have been used in clinical practice in infants with cholestasis and mostly give satisfactory results if given early before the baby is 2 months old. However, no randomized controlled trial (RCT) has been conducted to compare the improvement of cholestasis in infants receiving oral corticosteroids vs placebo (dummy drug). Until now there have been no publications on the use of corticosteroids as the main treatment of biliary atresia (bile duct blockage), although many experts believe that an immunological process (inflammatory and autoreactive) is the underlying cause. The aim of this study is to analyze the effect of giving oral methylprednisolone to infants with cholestasis on the improvement of jaundice, stool color, blood biochemical levels, and inflammatory markers.
Who can participate?
Patients aged 14 days to 3 months old with cholestasis
What does the study involve?
Participants are randomly allocated into two groups. The intervention group receive a combination of oral methylprednisolone (generic) and standard therapy for 14 days with dose 2 mg/kg/day in divided doses. The control group receive placebo and standard therapy for 14 days. Standard therapy given is urdafalk 10 mg/kg/time every 8 hours.
What are the possible benefits and risks of participating?
By participating in this study, parents get information about the condition of their child's disease because a complete examination is carried out and they will be followed up on a regular basis. Parents also get a souvenir.
There are several possible risks such as a chubby face (moon face), vomiting, diarrhea, and constipation. Drawing blood can cause risks such as pain and bruising at the needle puncture site. Even though all efforts have been made to minimize the risk in this study, there is always the possibility that undesirable things will occur, such as the child not feeling comfortable or other side effects of treatment, such as a moon face, vomiting, diarrhea, constipation, and disturbances in blood glucose levels that can occur from side effects of the treatment. Participants can withdraw from the study at any time.
Where is the study run from?
Dr Soetomo General Academic Hospital (Indonesia)
When is the study starting and how long is it expected to run for?
June 2022 to August 2023
Who is funding the study?
Kemdikbudristek (Indonesia)
Who is the main contact?
Bagus Setyoboedi, bagus.setyoboedi@fk.unair.ac.id
Contact information
Principal Investigator
Jl Prof Dr. Moestopo 6-8 Surabaya
Surabaya
60286
Indonesia
| Phone | +62 (0)8123560043 |
|---|---|
| bagus.setyoboedi@fk.unair.ac.id |
Study information
| Study design | Single interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of oral methylprednisolone as adjuvant therapy on clinical improvement, biochemical markers, and inflammation in infants with cholestasis |
| Study objectives | There is an effect of oral methylprednisolone in infants with cholestasis on the improvement of jaundice, stool color, blood biochemical levels (bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT]), and inflammatory markers |
| Ethics approval(s) | Approved 15/08/2022, Ethical Committee of Dr Soetomo General Academic Hospital, Surabaya, Indonesia (Jl Prof Dr. Moestopo 6-8 Surabaya, East Java, Indonesia; +62 (0)31 5501164; kepk@rsudrsoetomo.jatimprov.go.id), ref: 0648/KEPK/VIII/2022 |
| Health condition(s) or problem(s) studied | Cholestasis |
| Intervention | 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 mg/kg/day in divided doses. After 14 days of subjects receiving methylprednisolone, the observation is completed and the patient is continued with services according to the protocol. 2. Methylprednisolone (-)/control group: receive placebo and standard therapy for 14 days. Standard therapy given is urdafalk 10 mg/kg/time every 8 hours. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Metylprednisolone (generic) |
| Primary outcome measure | 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-γ, IL1β, IL2, IL4, IL6, IL10, TGF-β, ANCA) measured using ELISA at baseline and 14 days |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 22/06/2022 |
| Completion date | 01/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 14 Days |
| Upper age limit | 3 Months |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Suffered from cholestasis 2. Aged 14 days to 3 months old |
| Key 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 |
| Date of first enrolment | 13/10/2022 |
| Date of final enrolment | 15/07/2023 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Surabaya
60286
Indonesia
Sponsor information
University/education
Jl Prof Dr. Moestopo No 47 Surabaya
Surabaya
60132
Indonesia
| Phone | +62 (0)31 5020251 |
|---|---|
| info@fk.unair.ac.id | |
| Website | http://www.unair.ac.id/ |
"ROR" |
https://ror.org/04ctejd88 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Education, Culture, Research, and Technology, Ministry of Education, Culture, Research, and Technology, Republic of Indonesia, Kemdikbudristek, Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi, Republik Indonesia, Indonesia Ministry of Education, Culture, Research, and Technology, Indonesian Ministry of Education, Culture, Research, and Technology, Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi, MECRT, Kemdikbudristek
- Location
- Indonesia
Results and Publications
| Intention to publish date | 30/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Raw data including the characteristics of participants and laboratory results will be shared 1 year after the study and for 2 years with a link that will be available in the journal. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/07/2024 | 09/08/2024 | Yes | No |
Editorial Notes
09/08/2024: Publication reference and total final enrolment added.
28/10/2022: Trial's existence confirmed by the Ethical Committee of Dr Soetomo General Academic Hospital.
