Probiotics in Pediatric Chronic Cholestasis

University of Indonesia (UI)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Cholestatic Liver Disease

Treatments: Combination Product: probiotics; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04787419

20-07-0733

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 29 days to 215 months old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

probiotics

Experimental group

Description:

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.

Treatment:

Combination Product: probiotics

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo