Clinical trial NCT04231721: High Resolution Colonic Manometry in Relation to 3D-Transit Times in Healthy Controls.
Official title: High Resolution Colonic Manometry in Relation to 3D-Transit Times in Healthy Controls.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Colonic Motility
Keywords: Neurogastroenterology
Colonic motility
Manometry
High resolution colonic manometry
3D-Transit system
Healthy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2020-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All healthy individuals who meet the inclusion- and exclusion criteria can be enrolled in the study. The recruitment process will primarily take place through the Danish website "Forsoegspersoner.dk", which all Danish people have equal access to.

Brief summary: Background: Within recent years, new methods for detailed assessment of gastrointestinal (GI) motility have been developed. Hence, the electromagnetic 3D-Transit system is a safe, non-invasive method for detailed description of GI motility. The system tracks the exact position of an ingested electromagnetic capsule through the entire GI tract and provides detailed information on both regional transit- and contraction patterns. High Resolution Colonic Manometry (HRCM) allows extremely detailed description of contraction patterns in the colon. The HRCM is however an invasive method, as the catheter is placed during colonoscopy. Before widespread use of capsule-based techniques (3D-Transit or others), the system needs to be validated by another method.

Study Objectives: The purpose of this study is to investigate weather pressure changes measured by HRCM correlate with passage patterns recorded by 3D-Transit. This has been assumed so far, but has never been further investigated.

Hypothesis: Movement of the electromagnetic 3D-Transit capsule within the colon correspond well with pressure changes determined with HRCM.

Materials and methods: HRCM and 3D-transit will be performed simultaneously in 20 healthy participants. A colonoscopy is performed to install the HRCM catheter and place two 3D-Transit capsules within the colon. For 24 hours, the participants lie in a bed in the research lab while pressure changes from the HRCM catheter are recorded and the 3D-Transit capsules are followed through the gastrointestinal system.

Perspectives: If data from the 3D-Transit technique correlate well with HRCM, the method provide a non-invasive alternative allowing detailed assessment of colonic motility.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70
* Normal gastrointestinal function
* Psychologically able to give an informed content.

Exclusion Criteria:

* Known gastrointestinal disease
* Intake of medication with known effects on the movement patterns in the gastrointestinal system.
* Pregnancy and lactation
* Unable to follow the scheduled program in the trial due to mental illness or instability.

Primary outcomes:
measure: Correlation between pressure changes and passage patterns
timeFrame: 24 hours measurement
Secondary outcomes:
measure: Distance of capsule movement and pressure changes
timeFrame: 24 hours measurement
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Hepatology and Gastroenterology, Aarhus University Hospital
state: Aarhus N
Study officials:
affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital
name: Klaus Krogh, Professor
role: STUDY_DIRECTOR
References: