Probiotics in Pediatric Chronic Cholestasis
Primary Purpose
Cholestatic Liver Disease
Status
Active
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
placebo
probiotics
Sponsored by
About this trial
This is an interventional prevention trial for Cholestatic Liver Disease
Eligibility Criteria
Inclusion Criteria:
- diagnosed with chronic cholestasis (>4 weeks evidence of cholestasis from laboratory evidence)
- patient/guardian give consent to participate
Exclusion Criteria:
- 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)
Sites / Locations
- Cipto Mangunkusumo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
probiotics
placebo
Arm Description
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.
2 sachets per day for 4 weeks. 1 sachet of placebo (1gram) contains: saccharum lactis
Outcomes
Primary Outcome Measures
macroscopic fecal analysis
consistency of stool according to Bristol stool chart
microscopic fecal erythrocyte count
fecal erythrocyte count per high power field
microscopic fecal leukocyte count
fecal leukocyte count per high power field
fecal calprotectin
fecal calprotectin measured using ELISA technique, reported in micrograms/gram
gut microbiota diversity
PCR of gut microbiota diversity
presence of intestinal bacteria overgrowth
measured using hydrogen breath test
Secondary Outcome Measures
albumin
serum albumin level measured in umol/L
ALT
serum ALT measured in u/L
AST
serum AST measured in u/L
ALP
serum ALP measured in u/L
GGT
serum GGT measured in u/L
bilirubin level
serum total, direct and indirect bilirubin levels measured in u/L
incidence of diarrhea
any episode of diarrhea within intervention period (>3x/day, loose bowel, or exceeds usual frequency for infants)
antibiotic use
any antibiotic consumption as indicated by presence of infection (any organ system)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04787419
Brief Title
Probiotics in Pediatric Chronic Cholestasis
Official Title
The Role of Probiotics in Chronic Cholestasis to Prevent Gastrointestinal Diseases in Pediatric Patients in Cipto Mangunkusumo Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestatic Liver Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Both placebo and probiotics have the exact same packaging. batch production numbers are printed, ended with either "0" or "1". code will be revealed by third party (production and packaging team) upon study completion (following data analysis)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
probiotics
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
2 sachets per day for 4 weeks.
1 sachet of placebo (1gram) contains: saccharum lactis
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
saccharum lactis
Intervention Type
Combination Product
Intervention Name(s)
probiotics
Intervention Description
Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus
Primary Outcome Measure Information:
Title
macroscopic fecal analysis
Description
consistency of stool according to Bristol stool chart
Time Frame
28th day of product consumption
Title
microscopic fecal erythrocyte count
Description
fecal erythrocyte count per high power field
Time Frame
28th day of product consumption
Title
microscopic fecal leukocyte count
Description
fecal leukocyte count per high power field
Time Frame
28th day of product consumption
Title
fecal calprotectin
Description
fecal calprotectin measured using ELISA technique, reported in micrograms/gram
Time Frame
28th day of product consumption
Title
gut microbiota diversity
Description
PCR of gut microbiota diversity
Time Frame
28th day of product consumption
Title
presence of intestinal bacteria overgrowth
Description
measured using hydrogen breath test
Time Frame
28th day of product consumption
Secondary Outcome Measure Information:
Title
albumin
Description
serum albumin level measured in umol/L
Time Frame
28th day of product consumption
Title
ALT
Description
serum ALT measured in u/L
Time Frame
28th day of product consumption
Title
AST
Description
serum AST measured in u/L
Time Frame
28th day of product consumption
Title
ALP
Description
serum ALP measured in u/L
Time Frame
28th day of product consumption
Title
GGT
Description
serum GGT measured in u/L
Time Frame
28th day of product consumption
Title
bilirubin level
Description
serum total, direct and indirect bilirubin levels measured in u/L
Time Frame
28th day of product consumption
Title
incidence of diarrhea
Description
any episode of diarrhea within intervention period (>3x/day, loose bowel, or exceeds usual frequency for infants)
Time Frame
day 1- day 28 of product consumption
Title
antibiotic use
Description
any antibiotic consumption as indicated by presence of infection (any organ system)
Time Frame
day1 - day 28 of product consumption
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
215 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with chronic cholestasis (>4 weeks evidence of cholestasis from laboratory evidence)
patient/guardian give consent to participate
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Safira Alatas, MD, PhD
Organizational Affiliation
Department of Child Health Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Probiotics in Pediatric Chronic Cholestasis
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