Anti-LPS Antibody Treatment for Pediatric NAFLD

NCT03042767 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00084686
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (15)

• Percent Change in Fasting Glucose Level

  Baseline (Week 0), End of Treatment (Week 12)

• Change in Fasting Insulin Level

  Baseline (Week 0), End of Treatment (Week 12)

• Change in Hemoglobin A1C Level

  Baseline (Week 0), End of Treatment (Week 12)

• Change in Adipose Tissue Insulin Resistance (Adipo-IR)

  Baseline (Week 0), End of Treatment (Week 12)

• Change in Triglyceride/HDL (TG/HDL) Ratio

  Baseline (Week 0), End of Treatment (Week 12)

Study Arms (2)

IMM-124E Group

EXPERIMENTAL

Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks.

Biological: IMM-124E

Placebo Group

PLACEBO COMPARATOR

Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks.

Other: Placebo

Interventions

IMM-124E BIOLOGICAL

IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.

IMM-124E Group

Placebo OTHER

Matched Placebo

Placebo Group

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miriam Vos, MD: lead
• Advanced MR Analytics AB: collaborator
• Immuron Ltd.: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Miriam Vos
• Organization: Emory University

mvos@emory.edu

404-727-5383

Study Officials

• Miriam Vos, MD, MSPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 3, 2017
• Study Start: February 1, 2017
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: May 24, 2021
• Results First Posted: January 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)