Nonalcoholic Fatty Liver Disease (NAFLD)Phase 2NCT03042767
Anti-LPS Antibody Treatment for Pediatric NAFLD
A Phase 2 study testing IMM-124E in people with Nonalcoholic Fatty Liver Disease (NAFLD), run by Miriam Vos, MD at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- IMM-124E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 23 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease
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.
Read the 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.
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Being tested
- IMM-124E, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM-124EBiological
IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.
PlaceboOther
Matched Placebo
| Study group | Role | What they receive |
|---|---|---|
| IMM-124E Group | Experimental | Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks. Receives: Biological: IMM-124E |
| Placebo Group | Placebo comparator | Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Alanine Aminotransferase (ALT) Level
Percent change in ALT level from baseline to end of treatment.
Measured: Baseline (Week 0), End of Treatment (Week 12)
Secondary outcomes (15)
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.
Measured: Baseline (Week 0), End of Treatment (Week 12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in Waist Circumference
Waist circumference will be measured in centimeters using measuring tape.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Treatment (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonalcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miriam Vos, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced MR Analytics AB, Immuron Ltd.
- Responsible party
- Sponsor-investigator, Miriam Vos, MD, Emory University
- Investigators
- Miriam Vos, MD, MSPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042767
- Sponsor's protocol ID
- IRB00084686
- Status last verified
- Apr 2021
- First submitted
- 2 Feb 2017
- Last updated
- 24 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03042767
- Acronym / sponsor ID
- IRB00084686
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Miriam Vos, MDUniversity, hospital or other
- Collaborators
- Advanced MR Analytics AB, Immuron Ltd.
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMM-124E Group | Experimental | Biological: IMM-124EParticipants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks. |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM-124EIMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring. | Biological | IMM-124E Group |
| PlaceboMatched Placebo | Other | Placebo Group |
Primary outcome
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.
15 secondary outcomes
Percent Change in Fasting Glucose Level
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Change in Fasting Insulin Level
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Change in Hemoglobin A1C Level
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Change in Adipose Tissue Insulin Resistance (Adipo-IR)
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Change in Triglyceride/HDL (TG/HDL) Ratio
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in Blood Glucose Level
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Change in Insulin Levels
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in Body Mass Index (BMI) Z-Score
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in Visceral Adiposity
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in Hepatic Fat Percent
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in Waist Circumference
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in PROMIS Fatigue Questionnaire Score
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in PROMIS Depression Questionnaire Score
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Percent Change in PROMIS Anxiety Questionnaire Score
Time frame: Baseline (Week 0), End of Treatment (Week 12)
Composite Metabolic Improvement
Time frame: End of Treatment (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Vos, MD, MSPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMM-124E in people with Nonalcoholic Fatty Liver Disease (NAFLD), run by Miriam Vos, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Alanine Aminotransferase (ALT) Level (time frame: Baseline (Week 0), End of Treatment (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.