Probiotics in Pediatric Chronic Cholestasis

Cholestatic Liver Disease Clinical Trial

Official title:

The Role of Probiotics in Chronic Cholestasis to Prevent Gastrointestinal Diseases in Pediatric Patients in Cipto Mangunkusumo Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04787419
• Other study ID #: 20-07-0733
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Days to 215 Months

Eligibility

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)

Related Conditions & MeSH terms

• Cholestasis
• Cholestatic Liver Disease
• Liver Diseases

Intervention

Other:
• placebo
saccharum lactis

Combination Product:
• probiotics
Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macroscopic fecal analysis	consistency of stool according to Bristol stool chart	28th day of product consumption
Primary	microscopic fecal erythrocyte count	fecal erythrocyte count per high power field	28th day of product consumption
Primary	microscopic fecal leukocyte count	fecal leukocyte count per high power field	28th day of product consumption
Primary	fecal calprotectin	fecal calprotectin measured using ELISA technique, reported in micrograms/gram	28th day of product consumption
Primary	gut microbiota diversity	PCR of gut microbiota diversity	28th day of product consumption
Primary	presence of intestinal bacteria overgrowth	measured using hydrogen breath test	28th day of product consumption
Secondary	albumin	serum albumin level measured in umol/L	28th day of product consumption
Secondary	ALT	serum ALT measured in u/L	28th day of product consumption
Secondary	AST	serum AST measured in u/L	28th day of product consumption
Secondary	ALP	serum ALP measured in u/L	28th day of product consumption
Secondary	GGT	serum GGT measured in u/L	28th day of product consumption
Secondary	bilirubin level	serum total, direct and indirect bilirubin levels measured in u/L	28th day of product consumption
Secondary	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
Secondary	antibiotic use	any antibiotic consumption as indicated by presence of infection (any organ system)	day1 - day 28 of product consumption