Clinical trial NCT04787419: Probiotics in Pediatric Chronic Cholestasis
Official title: The Role of Probiotics in Chronic Cholestasis to Prevent Gastrointestinal Diseases in Pediatric Patients in Cipto Mangunkusumo Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cholestatic Liver Disease
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 29
Maximum age (years): 215
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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)

Primary outcomes:
measure: macroscopic fecal analysis
timeFrame: 28th day of product consumption
measure: microscopic fecal erythrocyte count
timeFrame: 28th day of product consumption
measure: microscopic fecal leukocyte count
timeFrame: 28th day of product consumption
measure: fecal calprotectin
timeFrame: 28th day of product consumption
measure: gut microbiota diversity
timeFrame: 28th day of product consumption
measure: presence of intestinal bacteria overgrowth
timeFrame: 28th day of product consumption
Secondary outcomes:
measure: albumin
timeFrame: 28th day of product consumption
measure: ALT
timeFrame: 28th day of product consumption
measure: AST
timeFrame: 28th day of product consumption
measure: ALP
timeFrame: 28th day of product consumption
measure: GGT
timeFrame: 28th day of product consumption
measure: bilirubin level
timeFrame: 28th day of product consumption
measure: incidence of diarrhea
timeFrame: day 1- day 28 of product consumption
measure: antibiotic use
timeFrame: day1 - day 28 of product consumption
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Department of Child Health Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia
name: Fatima Safira Alatas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: