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Anti-LPS Antibody Treatment for Pediatric NAFLD

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ClinicalTrials.gov Identifier: NCT03042767
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Advanced MR Analytics AB
Immuron Ltd.
Information provided by (Responsible Party):
Miriam Vos, MD, Emory University

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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease (NAFLD) Biological: IMM-124E Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


Arm Intervention/treatment
Experimental: IMM-124E Group
Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks.
Biological: IMM-124E
IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.

Placebo Comparator: Placebo Group
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Other: Placebo
Matched Placebo




Primary Outcome Measures :
  1. Percent Change in Alanine Aminotransferase (ALT) Level [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    Percent change in ALT level from baseline to end of treatment.


Secondary Outcome Measures :
  1. Change in Fasting Glucose Level [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    Fasting glucose level will be collected via blood draw. Change is the difference in glucose levels between baseline and end of treatment.

  2. Change in Fasting Insulin Level [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    Fasting insulin level will be collected via blood draw. Change is the difference in insulin level from baseline to end of treatment.

  3. Change in Hemoglobin A1C Level [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    Hemoglobin A1C Level will be collected via blood draw. Change is the difference in hemoglobin AIC level from baseline to end of treatment.

  4. Change in Adipose Tissue Insulin Resistance (Adipo-IR) [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    Adipo-IR will be collected via blood draw. It is calculated as fasting non-esterified fatty acids x fasting insulin.

  5. Change in Triglyceride/HDL (TG/HDL) Ratio [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    The TG/HDL ratio is the proportion of triglyceride levels in relation to HDL (good cholesterol). Change is defined as the difference in the TG/HDL ratio from baseline to the end of treatment.

  6. Change in Blood Glucose Level [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    The blood glucose level will be monitored via an oral glucose tolerance test (OGTT) at baseline and at the end of treatment. During the OGTT, the glucose level will be tested by a blood draw every thirty minutes for two hours. Change is described as the difference between glucose measurements taken at baseline and at the end of treatment.

  7. Change in Insulin Levels [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    The insulin level will be monitored via an oral glucose tolerance test (OGTT) at baseline and at the end of treatment. During the OGTT, the insulin level will be tested by a blood draw every thirty minutes for two hours. Change is described as the difference between insulin measurements taken at baseline and at the end of treatment.

  8. Change in Body Mass Index (BMI) Z-Score [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    BMI will be calculated from height and weight and converted into a z-score. Change is the difference in BMI z-scores from base line to end of treatment.

  9. Change in Visceral Adiposity [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    Visceral adiposity will be measured with a magnetic resonance imaging (MRI) scan. Visceral adipose tissue is a hormonally active component of total body fat.

  10. Change in Hepatic Fat Percent [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    Hepatic fat percent will be measured with a magnetic resonance imaging (MRI) scan. Hepatic fat percent is the percentage of fat within the liver.

  11. Change in Waist Circumference [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    Waist circumference will be measured in centimeters using measuring tape.

  12. Change in PROMIS Fatigue Questionnaire Score [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    The PROMIS Fatigue questionnaire evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. It assesses fatigue over the past seven days. A higher score represents more symptoms of fatigue.

  13. Change in PROMIS Depression Questionnaire Score [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    The PROMIS Depression instruments assess self-reported negative mood (sadness, guilt), views of self (selfcriticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). It assesses depression over the past seven days. A higher score represents more symptoms of depression.

  14. Change in PROMIS Anxiety Questionnaire Score [ Time Frame: Baseline (Week 0), End of Treatment (Week 12) ]
    The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Each assesses anxiety over the past seven days. A higher score represents more symptoms of anxiety.

  15. Composite Metabolic Improvement [ Time Frame: End of Treatment (Week 12) ]
    Composite metabolic improvement is defined as greater than 10% improvement in TG/HDL ratio, improvement in insulin resistance, and greater than 10% improvement in ALT.



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Ages Eligible for Study:   6 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042767


Contacts
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Contact: Rebecca Cleeton, MPH 404-727-5383 rcleeto@emory.edu

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rebecca Cleeton, MPH    404-727-5383    rcleeto@emory.edu   
Sponsors and Collaborators
Miriam Vos, MD
Advanced MR Analytics AB
Immuron Ltd.
Investigators
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Principal Investigator: Miriam Vos, MD, MSPH Emory University

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Responsible Party: Miriam Vos, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03042767     History of Changes
Other Study ID Numbers: IRB00084686
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs