Small Intestinal Function in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Small Intestinal Function in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01468428
• Other study ID #: UAarhus - VCF
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 7, 2011
• Last updated: November 10, 2011
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Gastrointestinal Motility

Locations

Country	Name	City	State
Denmark	Faculty of Healthy Sciencies	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	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.		No