Clinical trial NCT03042767: Anti-LPS Antibody Treatment for Pediatric NAFLD
Official title: Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Advanced MR Analytics AB
name: Immuron Ltd.
First posted: 2017-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change in Alanine Aminotransferase (ALT) Level
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
Secondary outcomes:
measure: Percent Change in Fasting Glucose Level
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Change in Fasting Insulin Level
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Change in Hemoglobin A1C Level
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Change in Adipose Tissue Insulin Resistance (Adipo-IR)
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Change in Triglyceride/HDL (TG/HDL) Ratio
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Percent Change in Blood Glucose Level
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Change in Insulin Levels
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Percent Change in Body Mass Index (BMI) Z-Score
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Percent Change in Visceral Adiposity
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Percent Change in Hepatic Fat Percent
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Percent Change in Waist Circumference
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Percent Change in PROMIS Fatigue Questionnaire Score
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Percent Change in PROMIS Depression Questionnaire Score
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Percent Change in PROMIS Anxiety Questionnaire Score
timeFrame: Baseline (Week 0), End of Treatment (Week 12)
measure: Composite Metabolic Improvement
timeFrame: End of Treatment (Week 12)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Miriam Vos, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: