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

Study Overview

• Status: Active, not recruiting
• Conditions: Cholestatic Liver Disease
• Intervention / Treatment: Combination product: probiotics; Other: placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: probiotics; Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus
Placebo Comparator: placebo; 2 sachets per day for 4 weeks. 1 sachet of placebo (1gram) contains: saccharum lactis	Other: placebo; saccharum lactis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
macroscopic fecal analysis	consistency of stool according to Bristol stool chart	28th day of product consumption
microscopic fecal erythrocyte count	fecal erythrocyte count per high power field	28th day of product consumption
microscopic fecal leukocyte count	fecal leukocyte count per high power field	28th day of product consumption
fecal calprotectin	fecal calprotectin measured using ELISA technique, reported in micrograms/gram	28th day of product consumption
gut microbiota diversity	PCR of gut microbiota diversity	28th day of product consumption
presence of intestinal bacteria overgrowth	measured using hydrogen breath test	28th day of product consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
albumin	serum albumin level measured in umol/L	28th day of product consumption
ALT	serum ALT measured in u/L	28th day of product consumption
AST	serum AST measured in u/L	28th day of product consumption
ALP	serum ALP measured in u/L	28th day of product consumption
GGT	serum GGT measured in u/L	28th day of product consumption
bilirubin level	serum total, direct and indirect bilirubin levels measured in u/L	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)	day 1- day 28 of product consumption
antibiotic use	any antibiotic consumption as indicated by presence of infection (any organ system)	day1 - day 28 of product consumption

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Fatima Safira Alatas, MD, PhD, Department of Child Health Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Liver Diseases; Cholestasis
• Other Study ID Numbers: 20-07-0733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No