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Small Intestinal Function in Patients With Cystic Fibrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by University of Aarhus.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468428
First Posted: November 9, 2011
Last Update Posted: November 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  Purpose

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.


Condition
Cystic Fibrosis Gastrointestinal Motility

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Small Intestinal Function in Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 15
Study Start Date: October 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • 15 CF patients with severe mutations and pancreatic insufficiency, without having diabetes or intestinal resection, with stable weight and no antibiotic treatment 14 days up to examination.
  • 15 age- and gender matched healthy controls
Criteria

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

Exclusion Criteria:

  • intestinal resection
  • lung transplantation
  • diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468428


Locations
Denmark
Faculty of Healthy Sciencies
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01468428     History of Changes
Other Study ID Numbers: UAarhus - VCF
First Submitted: November 7, 2011
First Posted: November 9, 2011
Last Update Posted: November 11, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases