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The purpose of this multi-center study is to determine whether SYNB1618 may be helpful in controlling phenylalanine (Phe) levels in patients with phenylketonuria (PKU), a rare genetic disorder. SYNB1618 is a type of probiotic that has been genetically modified to quickly break down Phe into non-toxic molecules. In people with PKU, an enzyme that does not work properly causes an accumulation of Phe, a protein, which can lead to intellectual disability and central nervous system problems. People with PKU must follow a restrictive diet to avoid foods containing Phe.
Subject to certain exclusion criteria, this study is enrolling adult participants who have classic PKU.
Males and Females: Ages 18 and older
Following initial screening, participants will be given special dietary instructions, which will be initiated 2 weeks prior to the dosing period and maintained throughout the course of the study. During the 2-week dosing period, participants will take the study drug up to three times a day, with dose levels increased every few days. Study visits will be scheduled for examinations and testing, and participants will be contacted by members of the study team by telephone in the intervals between visits.
Duration: Up to 95 days
Study Description at National Institutes of Health
Medical Genetics Research
Gerard Vockley, MD, PhD
For more information about the study or enrollment, please contact:
Jessica Lindenberger, MSN, CRNP, FNP-C
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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