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Anti-LPS Antibody Treatment for Pediatric NAFLD

NCT03042767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-05-24

Study results available
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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.

Conditions

  • Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

BIOLOGICAL

IMM-124E

IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.

OTHER

Placebo

Matched Placebo

Sponsors & Collaborators

  • Advanced MR Analytics AB

    collaborator INDUSTRY

  • Immuron Ltd.

    collaborator INDUSTRY

  • Miriam Vos, MD

    lead OTHER

Principal Investigators

  • Miriam Vos, MD, MSPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-10-23
Completion
2019-10-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03042767 on ClinicalTrials.gov