Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Constipation Craniocerebral Trauma Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Trauma, Nervous System Wounds and Injuries

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Gastrointestinal transit time (GITT) [in days]

Time frame: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.

Secondary outcomes

Association between heart rate variability (HRV) and GITT

Time frame: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.

Linear regression with GITT as dependent variable, and high frequency power sepectral density analysis of the heart rate (HF) as the independent variable.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Aarhus University Hospital
Regionshospitalet Hammel Neurocenter

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Apr 29, 2015
Registry last updated: Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed