Anti-LPS Antibody Treatment for Pediatric NAFLD

NCT ID: NCT03042767

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-10-23

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.

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IMM-124E Group

Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks.

Group Type: EXPERIMENTAL

IMM-124E

Intervention Type: BIOLOGICAL

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

Placebo Group

Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matched Placebo

Interventions

IMM-124E

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

Intervention Type: BIOLOGICAL

Placebo

Matched Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Nonalcoholic fatty liver disease (NAFLD) diagnosis confirmed by liver biopsy or MRI
• ALT ≥ 2 x ULN at screening (girls ≥ 46, boys ≥ 54)
• Written informed parent consent and child assent
• Willingness to take IMM-124E or placebo powder 3 x daily for 12 weeks
• At least 2 months of attempted lifestyle changes after diagnosis

Exclusion Criteria

• Disease or condition deemed by physician to interfere with absorption, digestion, or mechanism of intervention of drug
• Diagnosis of diabetes and an HbA1c of > 9%
• Change in supplement or anti-oxidant therapy within past 90 days (must be on a stable dose and willing to continue it throughout the trial or not on any vitamin or supplement, includes SAMe, vitamin E, betaine, Milk thistle etc)
• Use of probiotics or antibiotics in the past 30 days
• Use of anti-NAFLD medications (metformin, thiazolidinediones, UDCA) in the 30 days prior to randomization
• Acute illness within past 2 weeks prior to enrollment (defined as fever > 100.4ºF)
• Planned pregnancy, nursing an infant, confirmed or suspected to be pregnant between screening and time of study enrollment
• Evidence of other chronic liver disease other than NAFLD (Hepatitis B and C, Alpha-1 antitrypsin, Wilson's disease)
• Intolerance to lactose or dairy-based products
• Unable to have blood drawn at study visits
• Unwillingness to provide and/or collect stool samples
• Current gastrointestinal (GI) bleeding or inflammatory bowel disease (irritable bowel disease (IBD), colitis)
• Current enrollment in another therapeutic clinical trial or receipt of an investigational study drug within 6 months prior to study enrollment
• Participants who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced MR Analytics AB

INDUSTRY

Sponsor Role: collaborator

Immuron Ltd.

INDUSTRY

Sponsor Role: collaborator

Miriam Vos, MD

OTHER

Sponsor Role: lead

Responsible Party

Miriam Vos, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Miriam Vos, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00084686

Identifier Type: -

Identifier Source: org_study_id