NCT03042767

Anti-LPS Antibody Treatment for Pediatric NAFLD

Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Miriam Vos, MD · Academic / Other
• Sex: All
• Age: 6 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT). Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in treatment compared to placebo.

Detailed description

This is a randomized, double blind, placebo controlled, three month treatment trial of children aged 6-19 years. Participants will be recruited from the Children's Healthcare of Atlanta pediatric liver clinical practice.The purpose of this study is to evaluate if a three month treatment with IMM-124E (a bovine colostrum enriched with anti-LPS antibodies) in combination with standard of care lifestyle advice is safe and leads to greater improvement in hepatic inflammation, insulin sensitivity, and blood lipids in children with nonalcoholic fatty liver disease (NAFLD) compared to placebo with standard of care treatment. Investigators also seek to define the mechanism of action in response to three months of treatment with IMM-124E.

Conditions

• Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

Type	Name	Description
BIOLOGICAL	IMM-124E	IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.
OTHER	Placebo	Matched Placebo

Timeline

• Start date: 2017-02-01
• Primary completion: 2019-10-23
• Completion: 2019-10-23
• First posted: 2017-02-03
• Last updated: 2021-05-24
• Results posted: 2021-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study