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Clinical Trial

Offered by: Nemours Children's
Location: Delaware Valley

Trial Name

Interplay of Intestinal Microbiota and Bile Acids in Pediatric Nonalcoholic Fatty Liver Disease

What is the trial about?

We do not know why in some children fat accumulates in the liver (nonalcoholic fatty liver; NAFL) or in others it causes inflammation and scarring (called nonalcoholic steatohepatitis, NASH). We are trying to determine the role of gut microbiome and bile acid in this disease.

Who can participate?

Patients diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD) which includes NAFL (deposition of fat in the liver) or NASH (fat causing inflammation and scarring in the liver) who have already undergone liver biopsy (tissue sample taken from liver) will be enrolled in this study. Your child was diagnosed with NAFLD based on his/her liver biopsy, that is why you are being asked, if you are willing to have your child enrolled in this study.

What is involved?

We plan to enroll 20 patients with NAFLD (fat deposition in the liver or inflammation in liver due to fat). You and your child will drop off the stool sample and have blood drawn at the same time their labs are drawn as part of their routine clinical care and will complete and bring the 3 day food diary with you (before collection of stool sample). You and your child will not come for any further visits as part of the study but will come back only for their routine clinic visits.

As part of study you/your child need to provide a stool and blood sample. Your first meeting with member of research group, will be after your child's regular clinic visit and it will take an additional 20 minutes of your time. During that time you will be shown how to write down the 3 day food records (foods your child eats for 3 days before his/her next visit) and also how to collect a stool sample and how to transfer it back to the hospital. For the study visit you will bring 3 day food records, stools sample and your child will have blood drawn. The research group will be collecting the following de-identified data after your child’s clinic visit: weight, height, waist circumference, blood pressure, gender, ethnicity, blood test results, abdominal ultrasound and liver biopsy findings (if previously done as part of your child's routine clinical care).

Contact Nemours Children's Clinical Trials

Trial Name: Interplay of Intestinal Microbiota and Bile Acids in Pediatric Nonalcoholic Fatty Liver Disease

IRB#: 737252

(800) 354-5690 Email Us

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