Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome

Constipation Clinical Trial

Official title:

Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02459808
• Other study ID #: GBSTransitTimeAarhus
• Status: Withdrawn
• Phase: N/A
• First received: May 18, 2015
• Last updated: January 18, 2018
• Start date: May 2015

Study information

• Verified date: April 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constipation
• Guillain-Barre Syndrome
• Syndrome

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal transit time (GITT) [in days]		The measurement takes one week to perform. The investigators aim to start the measurement within one week after diagnosis.
Secondary	Association between heart rate variability (HRV) and GITT	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.