Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome

Withdrawn

• Conditions: Constipation; Guillain-Barre Syndrome

• Registration Number: NCT02459808
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study Start: 2015-05
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-02
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23
• Primary Completion: 2018-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Association between heart rate variability (HRV) and GITT	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.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark