Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome

January 18, 2018 updated by: University of Aarhus
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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at Aarhus University Hospital, admitted with Guillain-Barré syndrome.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
GBS Patients
Patients with Guillain-Barré syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
The measurement takes one week to perform. The investigators aim to start the measurement within one week after diagnosis.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The first HRV measurement is performed within one week after diagnosis. The second is performed 7 days after the first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Henning Andersen, Professor, Dr. med. PhD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBSTransitTimeAarhus

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Constipation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe