Small Intestinal Function in Patients With Cystic Fibrosis

• Conditions: Cystic Fibrosis; Gastrointestinal Motility

• Registration Number: NCT01468428
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10
• Status Verified: 2011-11
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-09
• Last Update Submitted: 2011-11-10
• Last Update Posted: 2011-11-11
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Cystic fibrosis, severe mutations
• Pancreatic insufficiency(Fecal elastase < 100 µg/g)
• Thriving, stabile weight over the last half year
• No treatment with antibiotics in the last 14 days up to the examination

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Exclusion Criteria

• intestinal resection
• lung transplantation
• diabetes

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Small intestinal transit time		MTS-1: A small magnet pill is ingested and its movements are monitored and recorded from mouth to caecum. The transit time of the stomach and small intestine is determined by real-time recordings.

Secondary Outcome Measures

Name	Time	Method
Colorectal transit time		Colorectal transit times are obtained using a plain abdominal x-ray after subjects has ingested 10 radiopaque markers on six consecutive days up to examination. The total number of markers in the entire colorectrum is counted and total as well as segmental transit times are calculated.

Trial Locations

Locations (1)

Faculty of Healthy Sciencies; 🇩🇰 Aarhus, Denmark