Anti-LPS Antibody Treatment for Pediatric NAFLD
Condition: Nonalcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: IMM-124E; Placebo
Intervention description: IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.; Matched Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 6 Years
Maximum age: 19 Years
Healthy volunteers: No

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.
    

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