Anti-LPS Antibody Treatment for Pediatric NAFLD

Miriam Vos, MD

Status and phase

Completed

Phase 2

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Treatments

Biological: IMM-124E

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03042767

IRB00084686

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

6 to 19 years old

Volunteers

No Healthy Volunteers

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