Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-11-30

Brief Summary

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Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied.

The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.

Detailed Description

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Conditions

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Brain Injury Constipation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ABI Patients

Patients with acquired brain injury.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ABI:
* Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission)
* or Stroke
* or Anoxic brain injury
* 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
* Known autonomic neuropathy
* Other known neurological disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henning Andersen, Professor, Dr. med. PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Other Identifiers

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ABITransitTimeHammel

Identifier Type: -

Identifier Source: org_study_id