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| Name | Class |
|---|---|
| Advanced MR Analytics AB | INDUSTRY |
| Immuron Ltd. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMM-124E Group | Experimental | Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks. |
|
| Placebo Group | Placebo Comparator | Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM-124E | Biological | IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Alanine Aminotransferase (ALT) Level | Percent change in ALT level from baseline to end of treatment. | Baseline (Week 0), End of Treatment (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Fasting Glucose Level | Fasting glucose level will be collected via blood draw. Percent Change in glucose levels between baseline and end of treatment. | Baseline (Week 0), End of Treatment (Week 12) |
| Change in Fasting Insulin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Vos, MD, MSPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
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40 participants were enrolled, 15 of them screenfailed. 25 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMM-124E Group | Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks. IMM-124E: IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring. |
| FG001 | Placebo Group | Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks. Placebo: Matched Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IMM-124E Group | Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks. IMM-124E: IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring. |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Alanine Aminotransferase (ALT) Level | Percent change in ALT level from baseline to end of treatment. | Posted | Mean | Standard Deviation | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMM-124E Group | Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks. IMM-124E: IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Miriam Vos | Emory University | 404-727-5383 | mvos@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 26, 2018 | Oct 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Other | Matched Placebo |
|
Fasting insulin level will be collected via blood draw. Change is the difference in insulin level from baseline to end of treatment.
| Baseline (Week 0), End of Treatment (Week 12) |
| Change in Hemoglobin A1C Level | Hemoglobin A1C Level will be collected via blood draw. Change is the difference in hemoglobin AIC level from baseline to end of treatment. | Baseline (Week 0), End of Treatment (Week 12) |
| Change in Adipose Tissue Insulin Resistance (Adipo-IR) | Adipo-IR will be collected via blood draw. It is calculated as fasting non-esterified fatty acids x fasting insulin. | Baseline (Week 0), End of Treatment (Week 12) |
| Change in Triglyceride/HDL (TG/HDL) Ratio | 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. | Baseline (Week 0), End of Treatment (Week 12) |
| Percent Change in Blood Glucose Level | 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. Percentage change between glucose measurements taken at baseline and at the end of treatment is reported. | Baseline (Week 0), End of Treatment (Week 12) |
| Change in Insulin Levels | 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. | Baseline (Week 0), End of Treatment (Week 12) |
| Percent Change in Body Mass Index (BMI) Z-Score | BMI will be calculated from height and weight and converted into a z-score. Body mass index z-scores are measures of relative weight adjusted for age and sex.Change is the difference in BMI z-scores from base line to end of treatment. | Baseline (Week 0), End of Treatment (Week 12) |
| Percent Change in Visceral Adiposity | Visceral adiposity will be measured with a magnetic resonance imaging (MRI) scan. Visceral adipose tissue is a hormonally active component of total body fat. | Baseline (Week 0), End of Treatment (Week 12) |
| Percent Change in Hepatic Fat Percent | Hepatic fat percent will be measured with a magnetic resonance imaging (MRI) scan. Hepatic fat percent is the percentage of fat within the liver. | Baseline (Week 0), End of Treatment (Week 12) |
| Percent Change in Waist Circumference | Waist circumference will be measured in centimeters using measuring tape. | Baseline (Week 0), End of Treatment (Week 12) |
| Percent Change in PROMIS Fatigue Questionnaire Score | 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. | Baseline (Week 0), End of Treatment (Week 12) |
| Percent Change in PROMIS Depression Questionnaire Score | 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. | Baseline (Week 0), End of Treatment (Week 12) |
| Percent Change in PROMIS Anxiety Questionnaire Score | 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. | Baseline (Week 0), End of Treatment (Week 12) |
| Composite Metabolic Improvement | 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. | End of Treatment (Week 12) |
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks. Placebo: Matched Placebo |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Percent Change in Fasting Glucose Level | Fasting glucose level will be collected via blood draw. Percent Change in glucose levels between baseline and end of treatment. | Posted | Median | Inter-Quartile Range | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Change in Fasting Insulin Level | Fasting insulin level will be collected via blood draw. Change is the difference in insulin level from baseline to end of treatment. | Data were not analyzed due to funding limitation. | Posted | Baseline (Week 0), End of Treatment (Week 12) |
|
|
| Secondary | Change in Hemoglobin A1C Level | Hemoglobin A1C Level will be collected via blood draw. Change is the difference in hemoglobin AIC level from baseline to end of treatment. | Data were not collected. Hemoglobin A1c was only used as a screening lab, it was not measured throughout the study - change cannot be measured | Posted | Baseline (Week 0), End of Treatment (Week 12) |
|
|
| Secondary | Change in Adipose Tissue Insulin Resistance (Adipo-IR) | Adipo-IR will be collected via blood draw. It is calculated as fasting non-esterified fatty acids x fasting insulin. | Data were not analyzed due to funding limitation. | Posted | Baseline (Week 0), End of Treatment (Week 12) |
|
|
| Secondary | Change in Triglyceride/HDL (TG/HDL) Ratio | 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. | Data were not analyzed due to funding limitation. | Posted | Baseline (Week 0), End of Treatment (Week 12) |
|
|
| Secondary | Percent Change in Blood Glucose Level | 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. Percentage change between glucose measurements taken at baseline and at the end of treatment is reported. | Posted | Median | Inter-Quartile Range | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Change in Insulin Levels | 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. | Data were not analyzed due to funding limitation. | Posted | Baseline (Week 0), End of Treatment (Week 12) |
|
|
| Secondary | Percent Change in Body Mass Index (BMI) Z-Score | BMI will be calculated from height and weight and converted into a z-score. Body mass index z-scores are measures of relative weight adjusted for age and sex.Change is the difference in BMI z-scores from base line to end of treatment. | Posted | Median | Inter-Quartile Range | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Percent Change in Visceral Adiposity | Visceral adiposity will be measured with a magnetic resonance imaging (MRI) scan. Visceral adipose tissue is a hormonally active component of total body fat. | Posted | Mean | Standard Deviation | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Percent Change in Hepatic Fat Percent | Hepatic fat percent will be measured with a magnetic resonance imaging (MRI) scan. Hepatic fat percent is the percentage of fat within the liver. | Posted | Mean | Standard Deviation | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Percent Change in Waist Circumference | Waist circumference will be measured in centimeters using measuring tape. | Posted | Median | Inter-Quartile Range | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Percent Change in PROMIS Fatigue Questionnaire Score | 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. | Posted | Mean | Standard Deviation | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Percent Change in PROMIS Depression Questionnaire Score | 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. | Posted | Mean | Standard Deviation | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Percent Change in PROMIS Anxiety Questionnaire Score | 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. | Posted | Mean | Standard Deviation | percentage change | Baseline (Week 0), End of Treatment (Week 12) |
|
|
|
| Secondary | Composite Metabolic Improvement | 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. | Data were not analyzed due to funding limitation. | Posted | End of Treatment (Week 12) |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 8 |
| 12 |
| EG001 | Placebo Group | Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks. Placebo: Matched Placebo | 0 | 13 | 0 | 13 | 10 | 13 |
| Abnormal glucose result | Endocrine disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomit | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
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