Newborn Lipase Fat Digestion Study

Molecular Mechanisms of Dietary Fat Digestion by Pancreatic Lipases – Fecal Fat and Duodenal Fluid Collection Research Studies

Protocol Description

In this study researchers are investigating whether babies with a genetic mutation in newborn lipase (an enzyme that digests fat) lose more fat in their stools than babies who do not have the genetic mutation, comparing newborns who are fed mothers’ milk to those who are fed formula. Researchers believe that if babies depend on newborn lipase, the absence of it would explain why some babies have trouble gaining weight. When babies do not digest fat as well as other babies, the undigested fat comes out in the stool. Understanding which lipase is important for fat digestion in babies will help researchers develop treatments to improve fat digestion and weight gain.

Eligibility Criteria

Subject to certain exclusion criteria, male and female babies with and without the genetic mutation who are in the neonatal intensive care unit (NICU) may be eligible for one of the two study subsets. Babies in the fecal fat subset must be less than a month old and on full feedings by bottle or tube; babies enrolled in the duodenal fluid subset must be less than 2 months old and receiving duodenal or jejunal tube feeds.
Male and Female Infants: Less than 1 month of age for fecal fat study or less than 2 months of age for duodenal fluid study.


A cheek swab sample will be obtained from participants to find out if they have the genetic mutation in the lipase. For the fecal fat study, stools will be collected from the newborns’ diapers over a 24-hour period for testing to see how much fat it contains. For fat content measurement, about 10 drops of mother’s milk will be collected from what remains after a feeding. For those enrolled in the duodenal fluid study, the duodenal/jejunal tube feed will be stopped long enough to obtain a sample of about 10 drops from the tube.
Visits: This study is only for infants in the NICU at Children’s Hospital of Pittsburgh of UPMC and Magee Women’s Hospital of UPMC
Duration: 48 hours

Status: Open to Enrollment

Source(s) of Support

National Institute of Diabetes and Digestive and Kidney Diseases

Additional Information

Gastroenterology Research

Primary Investigator

Mark Lowe, MD, PhD

Contact Information

For more information about the study or enrollment, please contact:
Maddie Schulte, RN
412- 692-5811