Probiotics in Pediatric Chronic Cholestasis

Phase 2

Active, not recruiting

• Conditions: Cholestatic Liver Disease
• Interventions: Combination Product: probiotics; Other: placebo

• Registration Number: NCT04787419
• Lead Sponsor: Indonesia University

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

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotics	probiotics	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.
placebo	placebo	2 sachets per day for 4 weeks. 1 sachet of placebo (1gram) contains: saccharum lactis

Primary Outcome Measures

Name	Time	Method
fecal calprotectin	28th day of product consumption	fecal calprotectin measured using ELISA technique, reported in micrograms/gram
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
presence of intestinal bacteria overgrowth	28th day of product consumption	measured using hydrogen breath test
microscopic fecal leukocyte count	28th day of product consumption	fecal leukocyte count per high power field
gut microbiota diversity	28th day of product consumption	PCR of gut microbiota diversity

Secondary Outcome Measures

Name	Time	Method
AST	28th day of product consumption	serum AST measured in u/L
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)
antibiotic use	day1 - day 28 of product consumption	any antibiotic consumption as indicated by presence of infection (any organ system)
ALP	28th day of product consumption	serum ALP measured in u/L
albumin	28th day of product consumption	serum albumin level measured in umol/L
GGT	28th day of product consumption	serum GGT measured in u/L
ALT	28th day of product consumption	serum ALT measured in u/L
bilirubin level	28th day of product consumption	serum total, direct and indirect bilirubin levels measured in u/L

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia