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Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04764019
Enrollment
50
Registered
2021-02-21
Start date
2018-11-07
Completion date
2022-02-28
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Motility Disorder

Brief 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.

Interventions

DIAGNOSTIC_TESTHigh resolution intestinal manometry

Evaluation of intestinal manometry by the use a high resolution intestinal manometry catheter with 34 closely spaced sensors.

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients: digestive symptoms * Healthy subjects: asymptomatic

Exclusion criteria

* Patients: organic disorders * Healthy subjects: organic disorders

Design outcomes

Primary

MeasureTime frameDescription
Contractile activity10 minutesNumber of contractions

Countries

Spain

Contacts

Primary ContactCarolina Malagelada, MD
cmalagelada@vhebron.net34 932746259
Backup ContactFernando Azpiroz, MD
azpiroz.fernando@gmail.com34932746259

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026