Phenylketonuria Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Children and teenagers with PKU:

• Children and teenagers aged 3 to 17 years old
• People who were diagnosed with phenylketonuria (PKU) through newborn screening
• People who are currently receiving ongoing medical care for PKU
• For the diet-only group: people whose PKU is managed through a special low-phenylalanine diet alone, without taking the medications sapropterin or sepiapterin
• For the sapropterin group: people who have been taking the medication sapropterin for at least three months in a row, and whose ability to eat natural protein has at least doubled compared to before starting the medication
• For the sepiapterin group: people who have been taking the medication sepiapterin for at least three months in a row, and whose ability to eat natural protein has at least doubled compared to before starting the medication

Healthy household members (controls):

• People aged 3 years or older who live in the same household as a child or teenager participating in the trial with PKU
• People with no known diagnosis of PKU or any other inherited metabolic condition

Who may not be able to join:

• People who were born with structural physical abnormalities (congenital malformations)
• People who have a long-term condition affecting the digestive system
• People who have a condition affecting the hormone system, liver, or kidneys
• People who have another ongoing medical condition that could affect the balance of bacteria in the gut
• People who have followed a special medical diet for any condition other than PKU at any point in the six months before providing a stool sample

Important: Always verify eligibility with the trial site directly before applying.