Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Gastrointestinal Motility Disorder Clinical Trial

Official title:

Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04764019
• Other study ID #: PR(AG)56/2018
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Carolina Malagelada, MD
• Phone: 34 932746259
• Email: cmalagelada[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. In patients with severe motor disorders, such as intestinal pseudo-obstruction, these new non-invasive techniques have shown to be equivalent to conventional intestinal manometry, the current gold-standard. However, these new techniques also detect less obvious signs of intestinal motor dysfunction, which are not detectable by conventional manometry.

High resolution manometry has been recently been applied to other parts of the digestive tract with great success, and probably will replace the actual gold-standard for intestinal motility evaluation. The investigators expect high-resolution manometry to be more sensitive than conventional manometry to the subtle motility disturbances detected by the new non-invasive techniques.

The purpose of this project is to demonstrate that intestinal motor function can be measured more sensitively and accurately using a combination of new technologies: high resolution manometry and the non-invasive diagnostic methods based on the analysis of images. The combined use of these techniques, following a step-wise algorithm, could allow to determine the mechanism, the affected regions and severity of the dysfunction in patients with intestinal dysmotility.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2022
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients: digestive symptoms

• Healthy subjects: asymptomatic

Exclusion Criteria:

• Patients: organic disorders

• Healthy subjects: organic disorders

Related Conditions & MeSH terms

• Gastrointestinal Motility Disorder

Intervention

Diagnostic Test:
• High resolution intestinal manometry
Evaluation of intestinal manometry by the use a high resolution intestinal manometry catheter with 34 closely spaced sensors.

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Malagelada C, Karunaratne TB, Accarino A, Cogliandro RF, Landolfi S, Gori A, Boschetti E, Malagelada JR, Stanghellini V, Azpiroz F, De Giorgio R. Comparison between small bowel manometric patterns and full-thickness biopsy histopathology in severe intestinal dysmotility. Neurogastroenterol Motil. 2018 Mar;30(3). doi: 10.1111/nmo.13219. Epub 2017 Sep 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contractile activity	Number of contractions	10 minutes