NCT04787419

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

February 9, 2021

Last Update Submit

March 1, 2023

Conditions

Cholestatic Liver Disease

Outcome Measures

Primary Outcomes (6)

  • macroscopic fecal analysis

    consistency of stool according to Bristol stool chart

    28th day of product consumption

  • microscopic fecal erythrocyte count

    fecal erythrocyte count per high power field

    28th day of product consumption

  • microscopic fecal leukocyte count

    fecal leukocyte count per high power field

    28th day of product consumption

  • fecal calprotectin

    fecal calprotectin measured using ELISA technique, reported in micrograms/gram

    28th day of product consumption

  • gut microbiota diversity

    PCR of gut microbiota diversity

    28th day of product consumption

  • presence of intestinal bacteria overgrowth

    measured using hydrogen breath test

    28th day of product consumption

Secondary Outcomes (8)

  • albumin

    28th day of product consumption

  • ALT

    28th day of product consumption

  • AST

    28th day of product consumption

  • ALP

    28th day of product consumption

  • GGT

    28th day of product consumption

  • +3 more secondary outcomes

Study Arms (2)

probiotics

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

placeboOTHER

saccharum lactis

placebo
probioticsCOMBINATION_PRODUCT

Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus

probiotics

Eligibility Criteria

Age29 Days - 215 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosed with chronic cholestasis (\>4 weeks evidence of cholestasis from laboratory evidence)
  • patient/guardian give consent to participate

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Fatima Safira Alatas, MD, PhD

    Department of Child Health Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric gastrohepatoenterologist consultant, clinical professor

Study Record Dates

First Submitted

February 9, 2021

First Posted

March 8, 2021

Study Start

September 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 3, 2023

Record last verified: 2023-03

Locations

ID(1)