Anti-LPS Antibody Treatment for Pediatric NAFLD

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Fatty Liver Disease (NAFLD)

In brief

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.

Key facts

Study ID

NCT03042767

Run by

Miriam Vos, MD

People needed

40

Starts

2017-02-01

Expected to finish

2019-10-23

Last updated by the study team

2021-05-24

Who can join

Age: 6 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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