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Intestinal Dysmotility in Patients With Functional Digestive Symptoms

NCT ID: NCT04764019

Last Updated: 2021-11-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Motility Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

Patients with chronic digestive symptoms in whom intestinal dysmotility is suspected

Group Type EXPERIMENTAL

High resolution intestinal manometry

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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High resolution intestinal manometry

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients: digestive symptoms
* Healthy subjects: asymptomatic

Exclusion Criteria

* Patients: organic disorders
* Healthy subjects: organic disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Carolina Malagelada, MD

Role: CONTACT

Phone: 34 932746259

Email: [email protected]

Fernando Azpiroz, MD

Role: CONTACT

Phone: 34932746259

Email: [email protected]

Facility Contacts

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Carolina Malagelada, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28941004 (View on PubMed)

Other Identifiers

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PR(AG)56/2018

Identifier Type: -

Identifier Source: org_study_id