Plastic Bronchitis and Protein Losing Enteropathy in Children With Single Ventricle Physiology

Completed

Conditions studied: Fontan Physiology Patients With PB or PLE, Fontan Physiology Patients Without PB or PLE

In brief

The investigators are studying what causes Plastic Bronchitis and Protein Losing Enteropathy. The investigators think that these problems are from too much of two small proteins called Vasoactive Intestinal Peptide (VIP) and Substance P. VIP and Substance P are important proteins in the body that normally tell the body to make small amounts of fluid and they help the intestines work. Normally, VIP and Substance P are made in the intestines and then destroyed in the lungs after they do their normal work. The investigators think that kids who have Plastic Bronchitis and/or Protein Losing Enteropathy who also had the Fontan surgery might have too much VIP and Substance P in their bodies. The investigators think this causes too much fluid to go in the lungs and too much protein in the intestines.

Key facts

Study ID

NCT01563757

Run by

Medical College of Wisconsin

People needed

20

Starts

2012-03-01

Expected to finish

2013-09-01

Last updated by the study team

2013-10-29

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fontan physiology patients with PB or PLE
• Fontan physiology patients without PB or PLE
• Glenn physiology patients
• 2 ventricle patients with Atrial Septal Defect
• Patient has scheduled cardiac catheterization (of right and left heart)
• Age is greater than 6 months
• Weight is greater than 10kg

You may not qualify if…

• Known Inflammatory Bowel Disease
• Hepatitis
• Congenital/ acquired liver disease
• Nephropathy
• Acute/ chronic renal dysfunction
• Active pulmonary hemorrhage
• Malignancy

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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