Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2

J
Jean Molleston, MD

Primary Investigator

Overview

The purpose of the NAFLD Pediatric Database 2 is to better understand nonalcoholic fatty liver disease (''NAFLD) by following and evaluating children with this condition yearly.

Description

The purpose of the NAFLD Pediatric Database 2 is to better understand nonalcoholic fatty liver disease (''NAFLD) by following and evaluating children with this condition yearly.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    nonalcoholic fatty liver disease,Nonalcoholic Fatty Liver Disease (NAFLD)
  • Age: Between 2 Years - 17 Years
  • Gender: All

Inclusion Criteria
(Previously Enrolled in the NAFLD Database Study or TONIC Trial)
Age at least 2 years and not older than 17 years during the consent process
Willingness to continue to be followed for up to 4 years
Ability and willingness to give written, informed parental consent and child assent, per local IRB guidelines, to be enrolled into the pediatric Database 2 study
Minimal or no alcohol use history consistent with NAFLD
(New participants)
Age at least 2 years of age and not older than 17 years during the consent process
Willingness to be followed for up to 4 years
Ability and willingness to give written, informed parent consent and child assent to be enrolled into the pediatric
Minimal or no alcohol use history consistent with NAFLD
Having undergone a liver biopsy that is obtained within 120 days of enrollment
Collection of biosamples (serum, plasma, DNA, and, if available, liver tissue) within 90 days prior to enrollment and 0-90 days before or 4-90 days after the standard of care liver biopsy
Exclusion Criteria
Short bowel syndrome
History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD
Known dysbetalipoproteinemia
Cystic fibrosis
Other metabolic or congenital liver disease
Evidence of systemic infectious disease
Known HIV positive
Disseminated or advanced malignancy
Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up


Additional Information:
Participants will be paid for their participation.

Updated on 09 Mar 2024. Study ID: 1010002429

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