Guillain-Barre SyndromeNCT02459808
Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome
An observational study of Guillain-Barre Syndrome and Constipation, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Guillain-Barre Syndrome, Constipation
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Aarhus University Hospital, admitted with Guillain-Barré syndrome.
Who may be able to join
- Guillain-Barré Syndrome
- Ability to swallow the capsules used to assess GITT
- Ability to give meaningful informed consent to participate in the study
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Guillain-Barre Syndrome, Constipation
- Medical subject headings
- Guillain-Barre Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GBS Patients | Patients with Guillain-Barré syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal transit time (GITT) [in days]
Measured: The measurement takes one week to perform. The investigators aim to start the measurement within one week after diagnosis.
Secondary outcomes (1)
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.
Measured: The first HRV measurement is performed within one week after diagnosis. The second is performed 7 days after the first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018 (estimated)
Why it stopped: Inclusion according to criteria was not practical in our setting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henning Andersen, Professor, Dr. med. PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459808
- Sponsor's protocol ID
- GBSTransitTimeAarhus
- Status last verified
- Apr 2015
- First submitted
- 18 May 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome
- ClinicalTrials.gov ID
- NCT02459808
- Acronym / sponsor ID
- GBSTransitTimeAarhus
- Conditions
- Guillain-Barre Syndrome, Constipation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Inclusion according to criteria was not practical in our setting.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBS Patients | – | –Patients with Guillain-Barré syndrome |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Aarhus University Hospital, admitted with Guillain-Barré syndrome.
Key inclusion criteria (3 listed)
- Guillain-Barré Syndrome
- Ability to swallow the capsules used to assess GITT
- Ability to give meaningful informed consent to participate in the study
Key exclusion criteria (6 listed)
- Major abdominal disorders
- Severe acute comorbidity
- Known cancer
- Pregnancy
- Other known neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Andersen, Professor, Dr. med. PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Guillain-Barre Syndrome and Constipation, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.