Small Bowel Motility in Patients With Systemic Sclerosis

January 11, 2022 updated by: Hospital Universitari Vall d'Hebron Research Institute

Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Several studies using intestinal manometry have reported alterations in small bowel motility in patients with systemic sclerosis. Our aim is to apply endoluminal image analysis to stratify the intestinal motor dysfunction in these patients can be assessed by non-invasive techniques. Consecutive patients with systemic sclerosis referred to our institution will be prospectively investigated using automated non-invasive techniques developed in our laboratory. Intraluminal images of the gut were obtained by capsule endoscopy. Endoluminal image analysis will be performed with original, previously validated programs based on computer vision and machine learning techniques.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemic sclerosis diagnosed by ACR criteria

Exclusion Criteria:

  • Lung transplantation
  • End stage kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Systemic sclerosis
Diagnostic test: Endoluminal image analysis by capsule endoscopy
Studies will be performed after discontinuation of medications that could affect gastrointestinal motility for at least 48 hours and overnight fast. Endoluminal images were obtained with the Pillcam capsule (Pillcam SB3 video capsule; Medtronic). Images will be obtained at a fixed 2 per second rate and recorded for a total of 8 hours with the subjects lying comfortably on a hospital bed and the trunk raised 30° above horizontal. Forty-five minutes after gastric exit, participants will be instructed to ingest a liquid meal (Ensure HN; Abbott; 300 mL,1 Kcal/mL). Endoluminal images of the small bowel will be analyzed with a computer program specifically developed in our laboratory for the evaluation of intestinal motility. This previously validated program is based on computer vision techniques, which allow the detection and quantification of contractile and non-contractile patterns characterizing small bowel motility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Motility index score
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)56/2018C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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