Cholestatic Liver Disease
Conditions
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
Interventions
OTHERplacebo
saccharum lactis
COMBINATION_PRODUCTprobiotics
Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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)
Eligibility
Sex/Gender
ALL
Age
29 Days to 215 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| macroscopic fecal analysis | 28th day of product consumption | consistency of stool according to Bristol stool chart |
| microscopic fecal erythrocyte count | 28th day of product consumption | fecal erythrocyte count per high power field |
| microscopic fecal leukocyte count | 28th day of product consumption | fecal leukocyte count per high power field |
| fecal calprotectin | 28th day of product consumption | fecal calprotectin measured using ELISA technique, reported in micrograms/gram |
| gut microbiota diversity | 28th day of product consumption | PCR of gut microbiota diversity |
| presence of intestinal bacteria overgrowth | 28th day of product consumption | measured using hydrogen breath test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of diarrhea | day 1- day 28 of product consumption | any episode of diarrhea within intervention period (\>3x/day, loose bowel, or exceeds usual frequency for infants) |
| albumin | 28th day of product consumption | serum albumin level measured in umol/L |
| antibiotic use | day1 - day 28 of product consumption | any antibiotic consumption as indicated by presence of infection (any organ system) |
| ALT | 28th day of product consumption | serum ALT measured in u/L |
| AST | 28th day of product consumption | serum AST measured in u/L |
| ALP | 28th day of product consumption | serum ALP measured in u/L |
| GGT | 28th day of product consumption | serum GGT measured in u/L |
| bilirubin level | 28th day of product consumption | serum total, direct and indirect bilirubin levels measured in u/L |
Countries
Indonesia
Outcome results
None listed