Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT03042767
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
19 Years
Study:
NCT03042767
Study Brief:
Protocol Section:
NCT03042767