Cholestatic Liver DiseasePhase 2/3NCT04787419
Probiotics in Pediatric Chronic Cholestasis
A Phase 2/3 study testing probiotics in people with Cholestatic Liver Disease, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
double blinded RCT (probiotics vs placebo) given to pediatric patients with chronic cholestasis for 4 weeks duration. baseline characteristics (antropometry, gastrointestinal symptoms, laboratory examinations) would be compared pre vs post treatment Read more about this study
- Who is it for?
- Ages 29 days to 215 months
- Conditions the study is for
- Cholestatic Liver Disease
- What is being tested?
- probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2020to 1 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 215 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with chronic cholestasis (>4 weeks evidence of cholestasis from laboratory evidence)
- patient/guardian give consent to participate
Who cannot join
- immunocompromised
- consumed antibiotic within 2 weeks prior to recruitment time
- patient already consuming probiotic-added formula (any probiotic supplementation or formula milk with added probiotic)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Role of Probiotics in Chronic Cholestasis to Prevent Gastrointestinal Diseases in Pediatric Patients in Cipto Mangunkusumo Hospital
double blinded RCT (probiotics vs placebo) given to pediatric patients with chronic cholestasis for 4 weeks duration. baseline characteristics (antropometry, gastrointestinal symptoms, laboratory examinations) would be compared pre vs post treatment
Read the detailed description
In mice model of cirrhosis and ascites, there is an increased intestinal permeability (leaky gut syndrome), subsequently leads to bacterial translocation. Bacterial translocation ultimately leads to bacterial overgrowth and increases associated morbidity, for instance, protracted diarrhea.
This RCT aims to administer probiotics product (lacto-B) in pediatric patients with chronic cholestasis (cholestasis > 4 weeks, evidenced from laboratory examination results).
method: double-blinded RCT
regimen: (identical, plain silver packaging, with code 0/1 --> revealed by 3rd party upon study completion)
intervention group: lacto-B 2 sachet per day for 4 weeks (28 days) each sachet of lacto-B contains: Viable Counts 1 x 107 CFU/g living bacteria in dual pH dependent release coated (Lactobacillus acidophilus, Bifidobacterium longum, Streptococcus thermophilus), Vitamin C 10 mg, Vitamin B1 0.5 mg, Vitamin B2 0.5 mg, Vitamin B6 0.5 mg, Niacin 2 mg.
control group: placebo sachet (saccharum lactis 1gr)
outcomes will be measured following completion of 4 weeks-course of probiotics/placebo
- Conditions
- Cholestatic Liver Disease
- Being tested
- placebo, probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
saccharum lactis
probioticsCombination product
Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus
| Study group | Role | What they receive |
|---|---|---|
| probiotics | Experimental | 2 sachets per day for 4 weeks.
1 sachet of probiotics (1gram) contains: Viable Counts 1 x 107 CFU/g living bacteria in dual pH dependent release coated (Lactobacillus acidophilus, Bifidobacterium longum, Streptococcus thermophilus), Vitamin C 10 mg, Vitamin B1 0.5 mg, Vitamin B2 0.5 mg, Vitamin B6 0.5 mg, Niacin 2 mg. Receives: Combination Product: probiotics |
| placebo | Placebo comparator | 2 sachets per day for 4 weeks.
1 sachet of placebo (1gram) contains: saccharum lactis Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
macroscopic fecal analysis
consistency of stool according to Bristol stool chart
Measured: 28th day of product consumption
microscopic fecal erythrocyte count
fecal erythrocyte count per high power field
Measured: 28th day of product consumption
microscopic fecal leukocyte count
fecal leukocyte count per high power field
Measured: 28th day of product consumption
fecal calprotectin
fecal calprotectin measured using ELISA technique, reported in micrograms/gram
Measured: 28th day of product consumption
gut microbiota diversity
PCR of gut microbiota diversity
Measured: 28th day of product consumption
presence of intestinal bacteria overgrowth
measured using hydrogen breath test
Measured: 28th day of product consumption
Secondary outcomes (8)
albumin
serum albumin level measured in umol/L
Measured: 28th day of product consumption
ALT
serum ALT measured in u/L
Measured: 28th day of product consumption
AST
serum AST measured in u/L
Measured: 28th day of product consumption
ALP
serum ALP measured in u/L
Measured: 28th day of product consumption
GGT
serum GGT measured in u/L
Measured: 28th day of product consumption
bilirubin level
serum total, direct and indirect bilirubin levels measured in u/L
Measured: 28th day of product consumption
incidence of diarrhea
any episode of diarrhea within intervention period (>3x/day, loose bowel, or exceeds usual frequency for infants)
Measured: day 1- day 28 of product consumption
antibiotic use
any antibiotic consumption as indicated by presence of infection (any organ system)
Measured: day1 - day 28 of product consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Sep 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholestatic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Fatima Safira Alatas, SpA(K), PhD, Universitas Indonesia
- Investigators
- Fatima Safira Alatas, MD, PhD, Principal investigator, Department of Child Health Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787419
- Sponsor's protocol ID
- 20-07-0733
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Probiotics in Chronic Cholestasis to Prevent Gastrointestinal Diseases in Pediatric Patients in Cipto Mangunkusumo Hospital
- ClinicalTrials.gov ID
- NCT04787419
- Acronym / sponsor ID
- 20-07-0733
- Conditions
- Cholestatic Liver Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
double blinded RCT (probiotics vs placebo) given to pediatric patients with chronic cholestasis for 4 weeks duration. baseline characteristics (antropometry, gastrointestinal symptoms, laboratory examinations) would be compared pre vs post treatment
Detailed description
In mice model of cirrhosis and ascites, there is an increased intestinal permeability (leaky gut syndrome), subsequently leads to bacterial translocation. Bacterial translocation ultimately leads to bacterial overgrowth and increases associated morbidity, for instance, protracted diarrhea.
This RCT aims to administer probiotics product (lacto-B) in pediatric patients with chronic cholestasis (cholestasis > 4 weeks, evidenced from laboratory examination results).
method: double-blinded RCT
regimen: (identical, plain silver packaging, with code 0/1 --> revealed by 3rd party upon study completion)
intervention group: lacto-B 2 sachet per day for 4 weeks (28 days) each sachet of lacto-B contains: Viable Counts 1 x 107 CFU/g living bacteria in dual pH dependent release coated (Lactobacillus acidophilus, Bifidobacterium longum, Streptococcus thermophilus), Vitamin C 10 mg, Vitamin B1 0.5 mg, Vitamin B2 0.5 mg, Vitamin B6 0.5 mg, Niacin 2 mg.
control group: placebo sachet (saccharum lactis 1gr)
outcomes will be measured following completion of 4 weeks-course of probiotics/placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotics | Experimental | Combination Product: probiotics2 sachets per day for 4 weeks. 1 sachet of probiotics (1gram) contains: Viable Counts 1 x 107 CFU/g living bacteria in dual pH dependent release coated (Lactobacillus acidophilus, Bifidobacterium longum, Streptococcus thermophilus), Vitamin C 10 mg, Vitamin B1 0.5 mg, Vitamin B2 0.5 mg, Vitamin B6 0.5 mg, Niacin 2 mg. |
| placebo | Placebo comparator | Other: placebo2 sachets per day for 4 weeks. 1 sachet of placebo (1gram) contains: saccharum lactis |
Who may qualify
- Ages
- 29 days to 215 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosed with chronic cholestasis (>4 weeks evidence of cholestasis from laboratory evidence)
- patient/guardian give consent to participate
Key exclusion criteria (3 listed)
- immunocompromised
- consumed antibiotic within 2 weeks prior to recruitment time
- patient already consuming probiotic-added formula (any probiotic supplementation or formula milk with added probiotic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebosaccharum lactis | Other | placebo |
| probioticsLactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus | Combination product | probiotics |
Primary outcome
macroscopic fecal analysis
Time frame: 28th day of product consumption
consistency of stool according to Bristol stool chart
microscopic fecal erythrocyte count
Time frame: 28th day of product consumption
fecal erythrocyte count per high power field
microscopic fecal leukocyte count
Time frame: 28th day of product consumption
fecal leukocyte count per high power field
fecal calprotectin
Time frame: 28th day of product consumption
fecal calprotectin measured using ELISA technique, reported in micrograms/gram
gut microbiota diversity
Time frame: 28th day of product consumption
PCR of gut microbiota diversity
presence of intestinal bacteria overgrowth
Time frame: 28th day of product consumption
measured using hydrogen breath test
8 secondary outcomes
albumin
Time frame: 28th day of product consumption
ALT
Time frame: 28th day of product consumption
AST
Time frame: 28th day of product consumption
ALP
Time frame: 28th day of product consumption
GGT
Time frame: 28th day of product consumption
bilirubin level
Time frame: 28th day of product consumption
incidence of diarrhea
Time frame: day 1- day 28 of product consumption
antibiotic use
Time frame: day1 - day 28 of product consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Safira Alatas, MD, PhD principal investigator
Department of Child Health Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing probiotics in people with Cholestatic Liver Disease, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
macroscopic fecal analysis (time frame: 28th day of product consumption). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.