Small Bowel Motility in Patients With Systemic Sclerosis
NCT ID: NCT05205239
Last Updated: 2022-01-25
Study Results
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-07-01
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Systemic sclerosis
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* End stage kidney disease
18 Years
80 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Hospital Vall d'Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Malagelada C, Drozdzal M, Segui S, Mendez S, Vitria J, Radeva P, Santos J, Accarino A, Malagelada JR, Azpiroz F. Classification of functional bowel disorders by objective physiological criteria based on endoluminal image analysis. Am J Physiol Gastrointest Liver Physiol. 2015 Sep 15;309(6):G413-9. doi: 10.1152/ajpgi.00193.2015. Epub 2015 Aug 6.
Segui S, Drozdzal M, Pascual G, Radeva P, Malagelada C, Azpiroz F, Vitria J. Generic feature learning for wireless capsule endoscopy analysis. Comput Biol Med. 2016 Dec 1;79:163-172. doi: 10.1016/j.compbiomed.2016.10.011. Epub 2016 Oct 19.
Malagelada C, Bendezu RA, Segui S, Vitria J, Merino X, Nieto A, Sihuay D, Accarino A, Molero X, Azpiroz F. Motor dysfunction of the gut in cystic fibrosis. Neurogastroenterol Motil. 2020 Sep;32(9):e13883. doi: 10.1111/nmo.13883. Epub 2020 May 31.
Other Identifiers
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PR(AG)56/2018C
Identifier Type: -
Identifier Source: org_study_id
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