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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
saccharum lactis
Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
macroscopic fecal analysis
consistency of stool according to Bristol stool chart
Time frame: 28th day of product consumption
microscopic fecal erythrocyte count
fecal erythrocyte count per high power field
Time frame: 28th day of product consumption
microscopic fecal leukocyte count
fecal leukocyte count per high power field
Time frame: 28th day of product consumption
fecal calprotectin
fecal calprotectin measured using ELISA technique, reported in micrograms/gram
Time frame: 28th day of product consumption
gut microbiota diversity
PCR of gut microbiota diversity
Time frame: 28th day of product consumption
presence of intestinal bacteria overgrowth
measured using hydrogen breath test
Time frame: 28th day of product consumption
albumin
serum albumin level measured in umol/L
Time frame: 28th day of product consumption
ALT
serum ALT measured in u/L
Time frame: 28th day of product consumption
AST
serum AST measured in u/L
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Time frame: 28th day of product consumption
ALP
serum ALP measured in u/L
Time frame: 28th day of product consumption
GGT
serum GGT measured in u/L
Time frame: 28th day of product consumption
bilirubin level
serum total, direct and indirect bilirubin levels measured in u/L
Time frame: 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)
Time frame: day 1- day 28 of product consumption
antibiotic use
any antibiotic consumption as indicated by presence of infection (any organ system)
Time frame: day1 - day 28 of product consumption