Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome

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.
ClinicalTrials.gov Identifier: NCT02459808
Recruitment Status : Withdrawn (Inclusion according to criteria was not practical in our setting.)
First Posted : June 2, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
Constipation is a common condition among patients with Guillain-Barré Syndrome. It is believed, that the constipation is caused by autonomic neuropathy. However, the severity of the constipation, and its relation to autonomic function have not previously been studied.

Condition or disease
Guillain-Barre Syndrome Constipation

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome
Study Start Date : May 2015
Estimated Primary Completion Date : May 2018


Group/Cohort
GBS Patients
Patients with Guillain-Barré syndrome



Primary Outcome Measures :
  1. Gastrointestinal transit time (GITT) [in days] [ Time Frame: The measurement takes one week to perform. The investigators aim to start the measurement within one week after diagnosis. ]

Secondary Outcome Measures :
  1. Association between heart rate variability (HRV) and GITT [ Time Frame: The first HRV measurement is performed within one week after diagnosis. The second is performed 7 days after the first. ]
    Linear regression with GITT as dependent variable, and high frequency power spectral density analysis of the heart rate (HF) as the independent variable. The mean HF of the first and second HRV measurement is used for this regression.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Aarhus University Hospital, admitted with Guillain-Barré syndrome.
Criteria

Inclusion Criteria:

  • Guillain-Barré Syndrome
  • Ability to swallow the capsules used to assess GITT
  • Ability to give meaningful informed consent to participate in the study

Exclusion Criteria:

  • Major abdominal disorders
  • Severe acute comorbidity
  • Known cancer
  • Pregnancy
  • Other known neurological disorder
  • Use of laxatives one week before inclusion. (Patients will be excluded if medication with laxatives is started during the one week GITT measurement)

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): NCT02459808


Locations
Layout table for location information
Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: Henning Andersen, Professor, Dr. med. PhD Aarhus University Hospital

Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02459808     History of Changes
Other Study ID Numbers: GBSTransitTimeAarhus
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: April 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Guillain-Barre Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases