Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 6:19 AM
Study NCT ID:
NCT03042767
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anti-LPS Antibody Treatment for Pediatric NAFLD
Sponsor:
Miriam Vos, MD
Organization:
Study Overview
Official Title:
Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: