Cystic Fibrosis Clinical Trial
Official title:
Small Intestinal Function in Patients With Cystic Fibrosis
In patients with Cystic fibrosis (CF) epithelial transport of chloride and sodium is
disrupted in several organs such as airways, sweat glands, pancreas and intestines.
Gastrointestinal symptoms are frequent but little is known about intestinal motility and
function. Earlier studies using lactulose/hydrogen breath tests have found altered
intestinal transit time. The method has several sources of errors and results have been
questioned. This study is using a new, non invasive method to study intestinal motility
patterns and transit times, Magnetic Tracking System - 1 (MTS-1).
The aim is to compare patterns of contractility and transit times in the stomach and small
intestine in adult CF- patients with healthy controls.
Methods MTS-1 is performed without radiation and is associated with minimal discomfort for
subjects. A small magnetic pill is ingest and detected by a matrix of sensors. Position and
orientation of the magnet are defined by five coordinates (position: x, y, z, angle: φ, θ).
Frequencies of slow waves as well as number and power of phase III contractions can be
identified.
Colorectal transit times are determined with a plain abdominal x-ray. The subjects are asked
to ingest a capsule containing 10 radiopaque markers on six consecutive days up to
examination. The total number of markers in the entire colorectum is counted. Total transit
time, as well as segmental is calculated.
Subjects 15 adult patients (> 18 years) with CF, homozygote for the mutation ΔF508, are
studied. They are all pancreas insufficient (fecal elastase < 100 µg/g), with no previous
intestinal resection or lung transplantation. None of them have diabetes. Patients are all
in well-regulated pancreatic enzyme replacement therapy (PERT), thriving and with stabile
weight over the last half year. They have had no treatment with antibiotics in the last 14
days up to the examination.
The hypothesis is that patterns of contractility and transit times are the same for
CF-patients in well -regulated PERT as for healthy controls.
n/a
Observational Model: Case Control, Time Perspective: Prospective
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