Trial Outcomes & Findings for Anti-LPS Antibody Treatment for Pediatric NAFLD (NCT NCT03042767)
NCT ID: NCT03042767
Last Updated: 2021-05-24
Results Overview
Percent change in ALT level from baseline to end of treatment.
COMPLETED
PHASE2
40 participants
Baseline (Week 0), End of Treatment (Week 12)
2021-05-24
Participant Flow
40 participants were enrolled, 15 of them screenfailed. 25 participants were randomized.
Participant milestones
| Measure |
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.
|
Placebo Group
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Placebo Group
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Anti-LPS Antibody Treatment for Pediatric NAFLD
Baseline characteristics by cohort
| Measure |
IMM-124E Group
n=12 Participants
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.
|
Placebo Group
n=13 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)Percent change in ALT level from baseline to end of treatment.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in Alanine Aminotransferase (ALT) Level
|
11.99 percentage change
Standard Deviation 25.87
|
-7.99 percentage change
Standard Deviation 16.54
|
SECONDARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)Fasting glucose level will be collected via blood draw. Percent Change in glucose levels between baseline and end of treatment.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in Fasting Glucose Level
|
4.55 percentage change
Interval -1.14 to 16.05
|
1.11 percentage change
Interval -6.54 to 3.49
|
SECONDARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)Population: Data were not analyzed due to funding limitation.
Fasting insulin level will be collected via blood draw. Change is the difference in insulin level from baseline to end of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)Population: Data were not collected. Hemoglobin A1c was only used as a screening lab, it was not measured throughout the study - change cannot be measured
Hemoglobin A1C Level will be collected via blood draw. Change is the difference in hemoglobin AIC level from baseline to end of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)Population: Data were not analyzed due to funding limitation.
Adipo-IR will be collected via blood draw. It is calculated as fasting non-esterified fatty acids x fasting insulin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)Population: Data were not analyzed due to funding limitation.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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. Percentage change between glucose measurements taken at baseline and at the end of treatment is reported.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in Blood Glucose Level
|
2.11 percentage change
Interval -3.06 to 16.05
|
1.16 percentage change
Interval -6.54 to 3.49
|
SECONDARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)Population: Data were not analyzed due to funding limitation.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)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.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in Body Mass Index (BMI) Z-Score
|
1.66 percentage change
Interval -0.46 to 2.38
|
-0.48 percentage change
Interval -3.77 to 2.83
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in Visceral Adiposity
|
1.23 percentage change
Standard Deviation 8.63
|
1.77 percentage change
Standard Deviation 9.07
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in Hepatic Fat Percent
|
-5.70 percentage change
Standard Deviation 16.80
|
-6.61 percentage change
Standard Deviation 17.15
|
SECONDARY outcome
Timeframe: Baseline (Week 0), End of Treatment (Week 12)Waist circumference will be measured in centimeters using measuring tape.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in Waist Circumference
|
2.29 percentage change
Interval -0.88 to 4.29
|
0.76 percentage change
Interval -0.33 to 1.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in PROMIS Fatigue Questionnaire Score
|
-10.17 percentage change
Standard Deviation 14.90
|
-4.67 percentage change
Standard Deviation 17.18
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in PROMIS Depression Questionnaire Score
|
-7.68 percentage change
Standard Deviation 17.00
|
3.62 percentage change
Standard Deviation 11.97
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
IMM-124E Group
n=11 Participants
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.
|
Placebo Group
n=11 Participants
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
Percent Change in PROMIS Anxiety Questionnaire Score
|
-13.78 percentage change
Standard Deviation 16.39
|
-4.89 percentage change
Standard Deviation 13.89
|
SECONDARY outcome
Timeframe: End of Treatment (Week 12)Population: Data were not analyzed due to funding limitation.
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.
Outcome measures
Outcome data not reported
Adverse Events
IMM-124E Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IMM-124E Group
n=12 participants at risk
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.
|
Placebo Group
n=13 participants at risk
Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.
Placebo: Matched Placebo
|
|---|---|---|
|
General disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • 12 weeks
|
15.4%
2/13 • Number of events 2 • 12 weeks
|
|
Endocrine disorders
Abnormal glucose result
|
16.7%
2/12 • Number of events 3 • 12 weeks
|
38.5%
5/13 • Number of events 8 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 2 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Gastrointestinal disorders
Vomit
|
0.00%
0/12 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
General disorders
Headache
|
8.3%
1/12 • Number of events 1 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place