Probiotics in Pediatric Chronic Cholestasis

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

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

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)

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.

any episode of diarrhea within intervention period (>3x/day, loose bowel, or exceeds usual frequency for infants)

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)