Probiotics in Pediatric Chronic Cholestasis

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04787419

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cholestatic Liver Disease	Other: placebo Combination Product: probiotics	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

albumin [28th day of product consumption]
serum albumin level measured in umol/L
ALT [28th day of product consumption]
serum ALT measured in u/L
AST [28th day of product consumption]
serum AST measured in u/L
ALP [28th day of product consumption]
serum ALP measured in u/L
GGT [28th day of product consumption]
serum GGT measured in u/L
bilirubin level [28th day of product consumption]
serum total, direct and indirect bilirubin levels 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

29 Days to 215 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

dr. Fatima Safira Alatas, SpA(K), PhD, Pediatric gastrohepatoenterologist consultant, clinical professor, Indonesia University

ClinicalTrials.gov Identifier:

NCT04787419

Other Study ID Numbers:

20-07-0733

First Posted:

Mar 8, 2021

Last Update Posted:

Mar 8, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Cholestasis

Study Results

No Results Posted as of Mar 8, 2021