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Effect of prebiotic and probiotic mixture in the treatment of pediatric non-alcoholic fatty liver disease (NAFLD)

Effect of prebiotic and probiotic mixture in the treatment of pediatric non-alcoholic fatty liver disease : A Double-blinded Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170128001
Enrollment
Unknown
Registered
2017-01-28
Start date
2016-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese children with NAFLD

Interventions

Placebo contains Maldextrin 2.3g/sachet which look similar to pre&#45
pro biotic mixture,BIOLIFE A.B. PRE & PRO&#44
a powder mix in sachet which contains prebiotic & probiotics. The prebiotic used in this product is chicory inulin (2.24 gram/sachet). Inulin is a soluble dietary fiber and a natural prebiotic. The p
placebo (maltodextrin),powder mix containing chicory inulin&#44
Lactobacillus acidophilus LA5&#44
and Bifidobacterium lactis BB12

Sponsors

The Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Obese children with NAFLD, age 6 to 18 years - Obese is defined by weight more than 2SD in the same gender and same age. - NAFLD is defined by the presence of steatosis with controlled attenuation parameter (CAP) values ≥250 dB/m from Fibroscan with CAP.

Exclusion criteria

Exclusion criteria: 1.Fatty liver from metabolic liver disease, viral hepatitis, Wilson disease, autoimmune hepatitis 2.History of hepatotoxic drug or substance used 3.Allergic or serious ADR to probiotics and prebiotics 4.Poor compliance

Design outcomes

Primary

MeasureTime frame
Hepatic fat content 16 weeks controlled attenuation parameter (CAP) by fibroscan

Secondary

MeasureTime frame
Liver fibrosis 16 weeks Liver stiffness measurement (LSM) by fibroscan,Body mass index Z-score 16 weeks 2007 WHO child growth references

Countries

Thailand

Contacts

Public ContactHansamon Poparn

Chulalongkorn University

hansamonp@gmail.com+66863729229

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026