NCT04787419

Probiotics in Pediatric Chronic Cholestasis

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 29 Days – 215 Months
• Healthy volunteers: Not accepted

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

Conditions

• Cholestatic Liver Disease

Interventions

Type	Name	Description
OTHER	placebo	saccharum lactis
COMBINATION_PRODUCT	probiotics	Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-03-08
• Last updated: 2023-03-03

Locations

1 site across 1 country: Indonesia