Anti-LPS Antibody Treatment for Pediatric NAFLD

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.

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